Latest news with #SUBLOCADE
Associated Press
27-05-2025
- Business
- Associated Press
Indivior Announces Patrick Barry as Chief Commercial Officer
Seasoned commercial executive with more than 30 years of pharmaceutical experience RICHMOND, Va., May 27, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV) today announced the appointment of Patrick Barry as Chief Commercial Officer, effective June 2. In this role, Barry will lead the company's commercial growth strategy, execution, and operations as Indivior continues its mission to transform the treatment of opioid use disorder led by SUBLOCADE® (buprenorphine extended-release) Injection. Barry will join Indivior's executive committee. 'Patrick is an accomplished and respected commercial leader whose strong track record driving growth in branded medicines make him an excellent addition to the executive team,' said Joe Ciaffoni, Chief Executive Officer. 'Patrick's breadth and depth of commercial experience will be instrumental in delivering on the Company's potential.' Barry has more than 30 years of commercial leadership experience in the pharmaceutical industry. He brings a track record of building and transforming high-performing commercial organizations to deliver sustained revenue growth across multiple product portfolios. Prior to joining Indivior, Barry served since 2020 as executive vice president and chief commercial officer for Endo Pharmaceuticals. In this role he led all commercial activities across three U.S. business segments, including branded pharmaceuticals and a Canadian affiliate with full responsibility for approximately $2 billion in revenue. 'I am honored to join Indivior at such a pivotal time for the company,' said Barry. 'Indivior has built a strong foundation and is well-positioned to broaden its leadership position in opioid use disorder. I look forward to working with the team to grow SUBLOCADE and maximize the potential of the Indivior portfolio.' Prior to Endo, Barry spent over two decades at Sanofi with increasing levels of responsibility over a range of senior leadership positions, spanning specialty pharmaceuticals, injectables, medical aesthetics, and branded medicines, with demonstrated success in turnaround scenarios, product launches, and market development. Barry holds an MBA from Cornell University and a bachelor's degree in public relations and marketing from McKendree University. About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit to learn more. Connect with Indivior on LinkedIn by visiting View original content to download multimedia: SOURCE Indivior PLC
Yahoo
01-05-2025
- Health
- Yahoo
New Study Highlights Monthly SUBLOCADE® as a Potential Treatment Option for Opioid Use Disorder During and After Pregnancy
SUBLOCADE use during pregnancy showed no increased risk of birth defects, miscarriage, or maternal complications compared to general population rates RICHMOND, Va., May 1, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV) today announced the publication of a study "Monthly Buprenorphine Depot Injection (SUBLOCADE) for Opioid Use Disorder During Pregnancy" in the American Journal on Addictions, evaluating the use of SUBLOCADE for the treatment of opioid use disorder (OUD) during pregnancy and postpartum. Three sources of data evaluated in this retrospective study illustrated that the use of monthly SUBLOCADE during pregnancy demonstrated no increased risk and is consistent with the established buprenorphine safety profile.1 This retrospective study includes clinical case studies from four pregnant patients treated with monthly SUBLOCADE, postmarketing surveillance data covering more than five years, and a targeted literature review. In total, 322 reports of pregnancy exposures to SUBLOCADE were identified. Of the four patients included in the clinical practice case studies, all delivered full-term infants with normal birthweight, no fetal anomalies, and no need for treatment for neonatal opioid withdrawal syndrome (NOWS). "The findings shared in this manuscript support perinatal, patient-centered decision-making," said Melinda Ramage, FNP-BC, CARN-AP, LCAS, Director of the North Carolina Perinatal Substance Use Disorder Network and lead author of the publication. "Treatment is not one-size-fits-all, and it is important to explore safe and effective options for the mother–baby dyad." Between 2010 and 2017, opioid use during pregnancy dramatically increased, with a 131% increase in opioid use-related diagnoses at delivery in the U.S.2 The U.S. national maternal morbidity and mortality data reveal mental health and substance use disorders are the leading underlying cause of pregnancy-related deaths in 36 states. While pregnancy-associated overdose deaths have been steadily rising since 2007, those involving fentanyl and other synthetic opioids markedly increased from 5.73 to 9.47 deaths per 100,000 in a span of just 3 years (2017–2020), with most deaths occurring post-delivery.3 This study helps address the current knowledge gap with relevant experience from patients and prescribers who used monthly SUBLOCADE during pregnancy and/or postpartum. In addition to the case studies, the postmarketing surveillance data showed live births with no reported birth defects in the majority of known cases and rates of spontaneous abortion and other outcomes consistent with or lower than general population rates. Review of relevant literature also aligned with the findings from postmarketing and clinical data sources. These data highlight buprenorphine's established safety profile and offers practical insights into clinical care. "OUD patients who are pregnant run the risk of experiencing a number of negative health consequences, such as infection, overdose, severe maternal morbidity, postpartum readmission, and even death, and using opioids during pregnancy has been linked to poor results for both the fetus and the newborn," said Christian Heidbreder, Chief Scientific Officer at Indivior. "As public health professionals and policymakers look for ways to reduce maternal overdose deaths, this study offers important new information about how long-acting medications like SUBLOCADE might be incorporated into a broader strategy to increase access and enhance outcomes for families affected by OUD." Treatment decisions during pregnancy and postpartum should reflect a shared decision-making approach between providers and patients, aligning with clinical guidance and product labeling. The patient-centered model is especially critical when managing chronic conditions, like OUD, in the perinatal period. These data support consideration of using SUBLOCADE as part of evidence-based treatment options, which include offering or continuing perinatal medications for OUD, prioritizing patient stability when considering a change of existing pharmacotherapy in pregnancy and postpartum, and assessing the benefits and risks in a patient-centered framework. This is the largest amount of data available regarding the experience of pregnant patients on SUBLOCADE. Limitations of the study include limited descriptive data for case studies obtained from a small patient cohort and 21% of pregnancies reported outcomes for postmarketing surveillance. Disclosure:This work was funded by Indivior Inc., with the exception of the case studies and the time and contributions of Melinda Ramage, which were not supported by Indivior. About SUBLOCADE®SUBLOCADE ® (buprenorphine extended-release) injection, for subcutaneous use, CIII INDICATION AND HIGHLIGHTED SAFETY INFORMATIONINDICATIONSUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. HIGHLIGHTED SAFETY INFORMATIONWARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program call the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements. CONTRAINDICATIONSHypersensitivity to buprenorphine or any other ingredients in SUBLOCADE. WARNINGS AND PRECAUTIONSAddiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with of Serious Injection Site Reactions: Likelihood of may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema and pruritus with some involving abscess, ulceration and Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patients have tolerated transmucosal buprenorphine before injecting of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. ADVERSE REACTIONSAdverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain. For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit About Opioid Use Disorder (OUD)Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences. OUD may affect the parts of the brain that are necessary for life-sustaining functions. About IndiviorIndivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit to learn more. Connect with Indivior on LinkedIn by visiting References: Ramage M, Bishop B, Mangano V, Mankabady B. Monthly Buprenorphine Depot Injection (SUBLOCADE®) for Opioid Use Disorder During Pregnancy. Am J Addict. 2025. Hirai AH, Ko JY, Owens PL, Stocks C, Patrick SW. Neonatal abstinence syndrome and maternal opioid-related diagnoses in the US, 2010–2017. JAMA. 2021; 325(2): 146-155. doi:10.1001/jama.2020.24991 Bruzelius E, Martins SS. US trends in drug overdose mortality among pregnant and postpartum persons, 2017–2020. JAMA. 2022; 328(21): 2159-2161. doi:10.1001/jama.2022.17045 View original content to download multimedia: SOURCE Indivior PLC
Globe and Mail
24-04-2025
- Business
- Globe and Mail
Indivior (INDV) Q1 2025 Earnings Call
DATE CALL PARTICIPANTS Mark Crossley: Chief Executive Officer Ryan Preblick: Chief Financial Officer Christian Heidbreder: Chief Scientific Officer Jason Thompson: Investor Relations RISKS SUBLOCADE net revenue declined 2% year-over-year, primarily due to near-term funding challenges in the criminal justice system channel. Suboxone Film average share decreased approximately three percentage points versus the same year-ago quarter to about 15%. The company expects further price erosion for Suboxone Film throughout 2025 due to generic competition. Need a quote from one of our analysts? Email pr@ Total Net Revenue: $266 million, down 6% year-over-year in Q1 2025 due to Suboxone Film competition and PERSERIS discontinuation. SUBLOCADE Net Revenue: Declined 2% year-over-year in Q1 2025, with U.S. growth was offset by criminal justice system funding challenges. SUBLOCADE Patient Treatment: Approximately 170,700 patients were treated in the prior twelve-month period in the U.S., marking a 14% year-over-year increase. Non-GAAP Adjusted Operating Profit: Increased 10% versus the year-ago quarter, reflecting lower expenses partially offsetting revenue reduction. Cost Savings: On track to deliver over $100 million in gross savings for FY2025, with $50 million will be reinvested in SUBLOCADE and the pipeline throughout 2025. Gross Margin: 83% in Q1, down year-over-year due to absence of one-time benefit in Q1 2024. Non-GAAP Adjusted SG&A: $130 million, down 8% versus Q1 of last year due to streamlining actions and PERSERIS discontinuation. R&D Expenses: $22 million, a decrease of 19% versus Q1 2024, reflecting pipeline reprioritization. Cash Position: The company ended Q1 2025 with $400 million in gross cash and investments, which was higher than expected due to delayed Medicaid billing. SUMMARY Indivior reported Q1 2025 results aligned with expectations, while maintaining full-year 2025 guidance despite challenges in the criminal justice system channel. Management anticipates SUBLOCADE growth acceleration in the second half of 2025, driven by marketing initiatives and label enhancements. SUBLOCADE's new patient share averaged over 70%, excluding the justice system, and has remained stable for three quarters. The company is expanding alternate sites of care for SUBLOCADE administration, with partnerships now covering about 1,500 sites across the U.S. As of Q1 2025, nineteen states have received approval for Medicaid 1115 waivers to fund treatment in justice systems. "We're seeing the new cohorts or the experience dual prescribing cohorts, you know, which are remaining stable at 65, 35, you know, for SUBLOCADE." noted CEO Mark Crossley, indicating market stabilization in Q1 FY2025. The court granted Indivior's motion to dismiss U.S. shareholder claims, though plaintiffs have 30 days to amend their complaint. INDUSTRY GLOSSARY SUBLOCADE: Buprenorphine extended-release monthly injection for opioid use disorder treatment. Suboxone Film: Buprenorphine and naloxone sublingual film for opioid use disorder treatment. OPVEE (OpV): Nasal spray for opioid overdose reversal. LAI: Long-acting injectable medication. CGS: Criminal justice system, referring to a specific channel for SUBLOCADE distribution. OHS: Organized health system, a distribution channel for SUBLOCADE. Full Conference Call Transcript Operator: Good day, and thank you for standing by. Welcome to the Indivior PLC Q1 2025 earnings call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during this session, you will need to press star one one on your telephone. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your host today, Jason Thompson. Please go ahead. Jason Thompson: Thanks, Heidi, and good morning and good afternoon, everyone. Before we begin, I need to remind everyone that on today's call, we may make forward-looking statements that are subject to risks and uncertainties. Actual results may differ materially. We list the factors that may cause our results to be materially different on slide two of this presentation. We also may refer to non-GAAP measures, the reconciliations for which may also be found in the appendix to the presentation that is now posted on our website at I'll now turn the call over to Mark Crossley, our CEO. Thanks, Jason. Good morning, good afternoon, everyone. Thanks for joining us on this call. Mark Crossley: To discuss our financial and business performance during the first quarter of 2025. I'll start with a brief overview of the quarter, before handing it over to Ryan, our Chief Financial Officer, to discuss the financials. We'll then conclude with a Q&A session, during which we'll be joined by Christian Heidbreder, our Chief Scientific Officer. Turning to slide four. Overall results in the first quarter were in line with our expectations and consistent with our full-year 2025 outlook. Total net revenue in the quarter declined by 6% year on year. Results primarily reflect intensified competition from the generic film providers that resulted in lower Suboxone film pricing as well as the discontinuation of PERSERIS. This total net revenue performance was in line with our full-year net revenue outlook as was a modest 2% year-over-year decline in SUBLOCADE revenue in the quarter. As expected, SUBLOCADE net revenue performance in the quarter was primarily impacted by near-term justice system funding challenges. These impacts were partially offset by net revenue growth for SUBLOCADE in the organized health system channel. We ended the first quarter having treated approximately 170,700 patients in the prior twelve-month period in the U.S., which is a 14% increase year over year. Looking at patient dynamics, our analysis indicates that the US LAI category is continuing to stabilize with SUBLOCADE maintaining expected share. Setting aside the justice system, SUBLOCADE's new patient share averaged over 70% in the quarter, and has been stable for three quarters. Furthermore, our cohort analysis indicates that SUBLOCADE share among experienced dual prescribers has remained stable at approximately 65%. Our belief is that this stabilization of share reflects SUBLOCADE's unique product profile. Looking ahead, we continue to expect SUBLOCADE net revenue performance to improve in the second half of the year from the commercial investments we're making from the important label updates that we believe will further improve the patient and physician experience. Turning to non-GAAP adjusted operating profit. This increased by 10% versus the year-ago quarter, primarily reflecting lower expenses partially offsetting the reduction in total net revenue. Set against this, we've made good progress in our efforts to streamline our cost base and drive gross savings of over $100 million in 2025. Ryan will share more details on our streamlining progress in a moment. As we previously indicated, we're reinvesting approximately $50 million of these gross savings behind SUBLOCADE in our pipeline. While the balance of over $50 million will be used to protect our profit, and drop to the bottom line. Taken together, we're on track to deliver our full-year 2025 guidance. Lastly, as you're aware, I'll be stepping down as CEO of Indivior with anticipated effect from our AGM in May. It's been an immense privilege to lead Indivior over the past five years, and I'm proud of what we've achieved together. We've grown SUBLOCADE into an important treatment for opioid use disorder, and in doing so, we've helped many hundreds of thousands of patients on their path to recovery. Through our tireless efforts and advocacy, we've been on the front line of combating one of the biggest health epidemics of our times, and we've made great progress in derisking Indivior by clearing legacy issues so that we can fulfill our mission and vision unencumbered. With this strong foundation in place, I'm confident that our team, under Joe's leadership, will deliver on the next chapter of growth and value creation for Indivior and its stakeholders. I'd now like to hand the call over to Ryan. Ryan Preblick: Thanks, Mark, and good morning and good afternoon to everyone. Overall, as Mark mentioned, this quarter's financial performance aligned with our expectations we communicated in late February. Looking at the first quarter results in more detail, starting with the top line, total net revenue of $266 million declined 6% versus the year-ago quarter, driven by the expected competitive pressure in Suboxone film and our decision to discontinue PERSERIS last July. By geography, total US net revenue in the first quarter declined by 8%, versus the year-ago quarter driven by these same dynamics. Rest of world was up 3% on a reported and 1% on a constant currency basis. The rest of the world Q1 of last year was negatively impacted by shipment timing, as we had mentioned last year. Overall, SUBLOCADE's performance in Q1 was in line with our expectations. Total SUBLOCADE net revenue declined 2% in the first quarter, versus the same year-ago quarter. We continue to see good growth from SUBLOCADE outside the US net revenue up 8% to $13 million. SUBLOCADE's US performance reflected solid dispense volume growth in the OHS channel, that was partially offset by near-term funding challenges among certain justice system accounts that resulted in significantly lower dispense volume from this channel. Lower pricing from higher rebating activity and unfavorable channel mix resulted in modestly lower net revenue year over year. On a sequential basis, SUBLOCADE's US net revenue declined 9%, reflecting a 6% decline in dispense volume, coupled with destocking in the quarter. This performance coupled with our updated cohort and new patient share data reinforced the midpoint of our full-year guidance for SUBLOCADE net revenue of $725 million to $755 million, which we are confirming today. Opti net revenue was immaterial in the first quarter, as we continue to roll out trialing programs and work to ensure the medicine is included in standing orders across all states. We continue to expect full-year net revenue of $10 million to $15 million including an $8 million product order from BARDA. Turning to Suboxone Film in the US. The average share of approximately 15% in the first quarter was in line with our planning expectations and down approximately three percentage points versus the same year-ago quarter. The current quarter did benefit from a prior quarter trade spend release in the mid-single-digit millions. As we mentioned in February in our 2025 guidance discussion, the generic film price eroded at the end of full year 2024 and we took the appropriate actions to maintain formulary access in Q1. Our full-year 2025 guidance still assumes further price erosion throughout the year. As a reminder, we do not promote Suboxone film in the US. Moving down to P&L. Our first quarter gross margin of 83% was down versus the prior year quarter. Q1 2024 included the benefit of saleable process validation batches of SUBLOCADE, from our expanded production capacity by our contract manufacturer. I do want to briefly discuss a topic on most investors' minds these days. Tariffs. We are closely monitoring the evolving landscape mindful that these things change daily. As the landscape currently stands, and based upon the geographical makeup, of our primarily US cost of goods sold, and manufacturing activities, we believe the potential tariff impacts are manageable, and within our non-GAAP gross margin guidance range of a low to mid 80% for the full year. Moving on to operating expenses. Non-GAAP adjusted SG&A expenses were $130 million in the quarter, down 8% versus Q1 of last year. The decrease primarily reflects our streamlining actions, the discontinuation of PERSERIS, and an accrual release in the low to mid-single digits related to the mandated IRS Pharma branded fee, which still may have to be adjusted later in the year upon final invoice. R&D expenses were $22 million, a decrease of 19% versus Q1 of last year. This decrease reflects the reprioritization of pipeline activities solely to our Phase two OUD assets and the previously mentioned cost savings. Our first quarter non-GAAP adjusted operating income of $59 million was down 10% from Q1 of last year, due primarily to the Suboxone film and PERSERIS net revenue dynamics, partially offset by the streamlining activities on our cost basis. Non-GAAP adjusted net income of $51 million decreased 11% versus Q1 of last year reflecting the dynamics I just highlighted in addition to an increase in net finance expenses. Our effective tax rate for Q1 was 19%, primarily benefiting from certain UK deductions. For the full year, we are still expecting an effective tax rate of 22% to 25%. Lastly, on our P&L, our non-GAAP adjusted earnings per share decreased 2% to $0.41 reflecting a lower non-GAAP adjusted net income partially offset by an approximate 9% lower diluted share count. Quickly touching on the balance sheet. Our capital position, we ended the first quarter with gross cash and investments of $400 million higher than expected due to a decrease in net working capital from delayed Medicaid billing of approximately $100 million in the quarter. Material cash outflows during Q1 included scheduled annual settlement payments, of $65 million to the DOJ RB, and Humana and same team. Looking ahead, we expect to maintain good financial flexibility and to continue our disciplined capital allocation strategy. In the near term, as we discussed in February, this remains focused on reinvesting to fuel our base business towards our net revenue goals meeting our stakeholder obligations. Moving to slide eight. At this point in the year and with the visibility we have in trends for the balance of the year, remain confident we are on track to deliver financial results we articulated in February. Before concluding, we now expect to file our 10-Q early next week, which will contain relevant litigation developments. I'll simply note at this time that earlier this week, the court granted our motion to dismiss the US shareholder claims against us. Although the court granted the plaintiffs thirty days to amend their complaint. Also, we continue to make progress towards a definitive opioid MDL settlement consistent with our existing accrual. Beyond that, there are no other major litigation updates worth noting. I will now turn the call back over to Mark. Mark Crossley: Thank you, Ryan. So in summary, we delivered a first quarter performance that was in line with our planning assumptions and puts us on track to deliver on our 2025 commitments. With that, I'll open up the call to Q&A. Operator: Thank you. And wait for your name to be announced. To withdraw your question, please press 11 again. We will take our first question. And the first question comes from the line of Karl Burns from Northland Capital Markets. Please go ahead. Your line is open. Karl Burns: Thanks for the question, and congratulations on the quarter. I'm wondering if there are any proposals regarding Medicaid funding that might change your outlook. Thanks. Mark Crossley: Thanks for that, Karl. Listen. Similar to the tariffs and things that are going on there, this is an evolving sort of situation that continues to kind of day to day. So we're keeping a close eye on it. I think one of the positives we see is this continues to be a bipartisan issue. And when you look at the health agenda for the administration, one of the top six is both rescue and treatment for opioid use disorder. So we see a strong signal from the administration with their affinity for helping with the opioid epidemic. Karl Burns: Got it. Great. Thank you. Operator: We will take our next question. Your next question comes from the line of David Amsellem from Piper Sandler. Please go ahead. Your line is open. David Amsellem: Thanks. So I guess, a couple for me. Number one is, can you talk about when you think you'll start to see a return to growth for SUBLOCADE? And I guess where I'm going with this is how are you thinking about the competitive landscape stabilization in terms of the mix, between your competitor and SUBLOCADE in terms of new starts? How are you thinking about an eventual return to growth or just a better foot in the criminal justice system, which you cited as being an important driver? And then sort of with new leadership coming in, when are we going to start to get a better flavor for what you might do differently regarding your commercial strategy? I know there's a lot there, but I wanted to hit all the high notes. Thank you. Mark Crossley: No. There is a lot to unpack there, David. Let me start with your second question first because I think it's the easiest. Listen. I won't speak for Joe at all with regards to his initial impressions. What I will say is he has been active in his onboarding, and assuming things get shareholder approval at the AGM, he will come in immediately as CEO, and I'll leave him to speak about his impressions and his near-term actions. As it goes to the growth of SUBLOCADE, I think the guidance has been pretty clear with regards to, you know, we have this initial impact that really started right from the beginning of the first quarter with regards to the CGS funding issues, which has disproportionately impacted that. We talked about about a 30% impact. We see with our marketing initiatives, with our label enhancements, which, you know, enhance both the HCP and the patient experience, you know, we see growth on organized health system accelerating through the year as those new initiatives take hold. So very excited about that moving forward, and that's further reinforced by what we're continuing to see in the dynamics in the disease space. And, David, you talked about new patient share. You know, we've seen new patient share stabilize over the last three quarters. Seventy-two percent for SUBLOCADE in March, seventy-one percent in Q4, seventy-two percent in Q1. So very, very stabilized with regards to that. We're seeing the new cohorts or the experience dual prescribing cohorts, you know, which are remaining stable at 65, 35, you know, for SUBLOCADE. So we're seeing a very stable environment where the disease space is adjusted to the two players with SUBLOCADE as a clear leader in a heavily dominated synthetic opioid choice of an abuse substance. So that, for us, is very positive. We do expect that there are a number of providers that have not tried, you know, the competitive product yet. Expect that trial to continue through the year. So, you know, at that point, we'd expect the market to be stabilized out based on the two players and to be a little bit more, you know, status quo in '26 and beyond where you really are totally focused on category growth, getting more people into long-acting injectables and on their road to recovery. David Amsellem: K. Appreciate it. Thank you. Mark Crossley: Thank you, David. Operator: We will take our next question. Your next question comes from the line of Christian Glennie from Stifel. Please go ahead. Your line is open. Christian Glennie: Yep. Good morning, guys. Thanks for the first one then, please, just to touch on CGS dynamic. And then expectations for the rest of the year. It showed an accelerating decline in that as you guided. Versus sort of the previous quarters. But does this sort of set then a new base for that business that when you talk about sequential potential growth, stabilization, for SUBLOCADE overall, that it could also be the same scenario in the CGS part of the market. And is and then related to that, is there anything that sort of particularly changes the dynamic in terms of funding in this part of the market that you can see or something that sort of improves the funding as we step through the rest of this year? On the CGS? Thanks. Mark Crossley: No. Christian, thanks for holding me accountable on that question from David because I specifically address criminal justice. You know, we did see the budget hit. You know, right from the start in Q1, you know, and most of that has hit and will and a little bit more pull through in Q2. So we expect growth, you know, in criminal justice. You know, through on a quarter-over-quarter basis through the balance of the year as we add new systems, you know, and bring on new accounts. With regards to the overall funding environment, really, there's you know, we think these are short-term implications. Albeit it can be a bit lumpy with regards to account-to-account implications as they come, but you've got really three interventions that can happen you know, as justice systems move forward to get more funding. The first is they can ask to move budgets from operations over to their pharma. Right? And so, you know, they save on daily dosing, and they can shift that over, you know, to the pharma side. So that's one place they can do that. Obviously a much longer burn because many of these are government accounts and their budget cycles are quite long. The second is they can apply for, you know, abatement funds and grants you know, to help fund, and those are also longer cycle. The abatement funds are starting to work their way through the system bit so they can get those. And for me, most importantly, the last development is the Medicaid eleven fifteen waivers. What we're seeing here is we have 19 states that have had approval for these waivers. For me, it's a really strong sort of voice from the states with regards to their desire to fund and help patients you know, that are that get into recovery, while they're in the justice system. And we know 60% of our patients are in the justice system. And interestingly, in the 19 states that have received approval that still have to operationalize, which we expect to start in 2026, over 60% of the LAI category sort of volume is covered in those 19 states. So you've got a really concentrated sort of sort of space there in those 19. And then we know we've got another nine states that have applied for eleven fifteen waivers that still have to seek approval. So, you know, you could end up you know, very soon in a spot where almost 30 states have those eleven fifteen waivers, are working to operationalize and relieving some of that budget pressure moving forward. So hope that's helpful, perspective on the CGS, Christian. Christian Glennie: Yep. Thank you. No. That's helpful. And then just to clarify on the Q1, whether there's any notable impact as it relates to pricing and or destocking for SUBLOCADE. In the first quarter? Ryan Preblick: Yeah. Hi, Kristen. Good morning. No. Really, it was a fairly quiet quarter. There was some destock in Q1 in the mid-single digits. So that reversed out the stocking that we saw in the fourth quarter. But overall, beyond that, pricing was quiet. Christian Glennie: Okay. Thank you. And then maybe just one final thing. I mean, are you obviously, you've got the sort of fifty minutes of you've got the new label. You've got this, you know, fifty minutes to deploy in terms of marketing, market awareness, and marketing. What, you know, what should be the expectations around or how do you assess what, you know, what what the success looks like as a result of that marketing campaign and the new label? I mean, just to get a better sense for you know, how far you're into that. Obviously, label was fairly recently done. I don't know how aggressively you've pushed the button on that $50 million budget. Just a better understanding of how things might play out as it relates to some of these sort of potential things that may be more in your favor on the competitive front? Mark Crossley: Yeah. Thanks for that question, Christian. And it is a major initiative. You know? I mean, listen. With only two in ten patients in treatment, you know, at any point in time for opioid use disorder and only, you know, a million eight getting treatment over a twelve-month period, and then even worse, only seven to eight percent of those getting an LAI. There's a tremendous opportunity here for awareness and pull through of long-acting and specifically SUBLOCADE, which is why we think the label enhancement for rapid induction alternate sites of injection, and for an incremental dose, a second dose on day eight to accelerate the journey to therapeutic levels. Combined with the HCP and patient marketing, you know, is gonna help us achieve our guidance where we do have, you know, increased growth throughout the back half of the year because it takes time for those initiatives to take place. I think the good thing is we are seeing some leading indicators regards to digital impressions and brand searches. Which are indicating that the campaign is impactful. But what's really gonna be how we measure this is gonna be net revenue moving forward and growth of the long-acting category. And SUBLOCADE specifically. Christian Glennie: Okay. Thank you. Mark Crossley: Thank you, Christian. Operator: Thank you. We will take our next question. And your next question comes from the line of Chase Knickerbocker from Craig Hallum. Please go ahead. Your line is open. Chase Knickerbocker: Good morning. Thanks for the questions. Maybe just to start on Suboxone. So you guys lost 40 basis points of share, you know, only sequentially. And it certainly seems even with that kind of mid-single-digit million benefit that pricing held up certainly better than we had expected. Can you kind of walk us through what your guidance assumes from here? Obviously, no change to that guidance. But should we be thinking about additional pricing pressure from here? Or is all the kind of incremental decline from here based on the entrance of a fifth generic? Thanks. Brian? Ryan Preblick: Hey, Chase. Good morning. So, no, just to remind everyone, what happened here in a film environment. With the fourth generic coming in the marketplace, late 2023, the fourth player, engine has really started to drive price decay in the market, especially at the end of the year 2024. They dropped their price close to 15%. So what you're seeing so far Q1 played out as expected. We did take a price reduction to ensure strong, formulary position. But we are projecting in our guidance that that price erosion will continue even with the four generics in the marketplace. And if Teva does launch, that could factor in at some level, but at this point, with the four in there and the way they're operating, our assumption is the price will continue. And then the balance of the year-over-year net revenue decline is due to the share assumptions. Right? Typically, on a year-over-year basis, we lose about three share points. So, that's factored in as well. Mark Crossley: I think just beyond doubt on this, Chase, I think a lot of folks are having Teva be the driver of the price decline. And what we saw through last year was there's continuing pricing pressure through the year, accelerated in the fourth quarter. So with the four players today, there's pricing pressure in the market, and we built that into our guidance that that would continue. Chase Knickerbocker: Has there been further pricing pressure since that price action that you guys took in Q1? Has there been additional declines? Or is that pricing now consistent at least so far through Q2? Ryan Preblick: What happens typically and we look past or look back in a couple years, Q1 tends to be a little quiet as the contracts get stabilized across all the players. And then we typically see the pricing activity pick up between Q2 and Q4 again. Chase Knickerbocker: Got it. Thanks. And then, maybe just last for me. You know, obviously, you know, over a year since the Opie launch at this point, you just kind of walk investors through what we should be watching as kind of the clearing events for this starting to be a material asset for you guys? I mean, obviously, kind of knocking down state by state, but there's a number of states that you know, do have standing orders. And so can you just kind of walk us through what you see as the clearing event to make up the kind of the assets that you, you know, thought it was going to be? Mark Crossley: Yeah. Thanks for that, Chase. Listen. Not much has changed since we discussed this at the fiscal year-end results. You know, we thought we'd be further along at this point, given the significantly differentiated profile and the fact the only rescue medication specifically recognized in the label for effectiveness against synthetic opioids like fentanyl. You know, as we talked at the year, though, harm reduction voice has been louder and stronger. And the sphere precipitated withdrawal, you know, is only gonna be alleviated when we get real-world evidence. So, you know, 2025 into 2026, the major focus is on creating that bolus of real-world evidence. So that we can use that, you know, to put forward potential impacts of precipitated withdrawal. You know, in the meantime, we'll continue to engage with state and local policymakers, you know, key medical personnel, you know, to deliver on continued uptick in our experience program where we have over 70 municipalities that have taken on. In addition, you know, we continue to be proud of that partnership with BARDA. You know, they've made two one hundred thousand unit orders. We expect another one in 2025, and, obviously, we have that ten-year contract of over a hundred million dollars. So this year is really it's an evidence generation sort of year. Of which we can step forward, and that's what's implied in the guidance we gave. At fiscal year-end. Chase Knickerbocker: Thanks, Mark. Ryan Preblick: Thank you, Chase. Operator: Thank you. We will take our next question. Your next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead. Your line is open. Thibault Boutherin: Yes. Thank you very much. I got a few. So maybe in town. But starting just with SUBLOCADE, and mix. If you could just clarify because I think the release is talking about sort of price mix impact in Q1. I think you mentioned sort of CGS being lower in the mix and as well as for the rebate. But as I think you just said, Q1 was more quiet in terms of pricing. So just trying to kind of clarify here if you if we can start here. Mark Crossley: Ryan, would you like to talk about the price mix? Ryan Preblick: I would say it's just an it the base volumes, you know, were strong in terms of the dispenses, but, what we did have to call out some pricing mix as you're referencing. And when we lost some of the CGS business, which was quite profitable, that does impact our mix at some level. And then as we progress on our journey with SUBLOCADE, the state Medicaid mix grows as a percentage of our business as well. So that's what you're seeing in there. And then as I mentioned earlier, Q1 did include some destocking. After there was some stocking in Q4 of last year. Mark Crossley: So I think price across different channels is relatively stable. And what you're seeing is more mix across the different channels. And that's what's causing your, you know, if you're doing a per a units by per revenue, that's what's causing that deviation. Primarily, Thibault. Thibault Boutherin: Okay. Thank you for the clarification. And then I just want to come back on the CJ situation and just understand what's happening here because if we sort of back out everything, you know, it looks like sort of $100 million coming from CJS in 2024. Sort of January, maybe 01/1525. I think the comments for this year suggest sort of back to 100. And I understand there is a funding challenge headwind in '25, but how, you know, how in the first place were you able to grow so much in '24? And what has structurally changed, you know, since then that that expanded sort of, you know, coming back to 2023 levels? Yeah. Just trying to understand the dynamic and what has changed in the budget or funding or whatever that explains the start of, you know, step forward and step back. Mark Crossley: No. It's a fair question. And just to rewind the clock back to the fiscal year-end results, what's happened is there's a handful of accounts, very large accounts, that were unable to increase their budgets in the short term. You know, to be able to treat all patients and had to make a choice of do I move to orals and treat all my patients with buprenorphine treatment? Or do I do long-acting for a subset based on what's there? And they shifted over to orals because they wanted to be able to say they could treat all their patients suffering from opioid use disorder. For clarity, they're not moving to the competition. They're just moving to orals in the short term while they try and work through their budget issues, which we think, you know, in the short to medium term through the abatement funds, through potential in the next budget cycle, reallocation of funds from operations to pharma, and through the eleven fifteen waivers, we think that will eventually, you know, be alleviated. But that was the main impetus that drove, you know, drove the drop in our fiscal year guidance of about 30% that Ryan spoke to, you know, in February. Thibault Boutherin: You. And just a very last one, from me. You know, I think there was a topic around decoupling transcription from administration of SUBLOCADE and having partnership with specialty pharmacies, you know, to do the administration about it for the prescription, and that's something we haven't talked about in some time. So just wanted to know if, you know, what was the progress here, if it's maybe a bit slower than expected, if it's part of your growth expectations for H2. So just general data on that would be helpful. Mark Crossley: Yeah. We continue to make progress on the alternate sites of care, which really have a couple vectors that they help that we've talked. One is the independent physicians, you know, that don't want to deal with the administrative sort of nature of having the product on and things like that. And the other is the digital sort of side of things where, you know, within a digital medium, they obviously need to be able to send the patient somewhere else. We now have about eight partners. The initial one was Albertsons. We built that up to eight. We're over, you know, at about 1,500 sites across the US. We continue to look for more, you know, foundational partners with large either regional or major national sort of scope to round out this. We want the to be as frictionless, you know, as a retail experience or as close to that as it can be. So we're continuing to work with those partners in discussing the opportunity to have these alternate sites of care moving forward. Thibault Boutherin: Thank you very much. Mark Crossley: Thank you, Thibault. Appreciate it. Operator: Thank you. We will take our next question. Your next question comes from the line of Paul Cuddon from Deutsche. Please go ahead. Your line is open. Paul Cuddon: Yes. Thank you very much, and good morning, guys. I have two questions, please. Firstly, I know it's early, but I mean, you seen any impact on dual prescribing physicians with the kind of label change that sort of came earlier this year. And then secondly, on OpV, to what extent has Emergent Fire Solutions licensing of Cluxado kind of created an even stronger kind of market leader you're gonna find it increasingly challenged to get share from? Mark Crossley: I'll start with the first one, Paul. Listen. I think the impact of the dual of the label on dual prescribers, I think it's just too early. We're getting some subjective feedback that it's very positive. You know, having the only once monthly that can induct immediately, you know, have being able to induct in all of the alternate sites, you know, where the competitor can't do that in the back of the arm. You know, and having this dose which accelerates getting to therapeutic levels in an area where you have synthetic opioids out there, where if a patient relapses, they could die, you know, from synthetic opioids. We've heard subjectively it's there, and people really like the label update and the enhanced there. With OpV, it's it and Emergent, it's an interesting one, you know, that they've licensed in, you know, this higher dose naloxone because it's counter to some of the harm reduction sort of things that say we want the lowest dose possible, you know, and the fact that, you know, the people that have the market-leading product there are getting a higher dose product. To me, it says higher dose products certainly have a role in this market. And for me, it just further reinforces OpV's role, you know, as we move forward. Now that will take real-world evidence to deal and have data to deal with precipitated withdrawal. But the move to me further enhances the need for OpV in this space. Paul Cuddon: Great. Superb. And so I just have one more. I mean, just focusing a little bit on your net cash position and the kind of looming litigation payments through to January 2027. I mean, how are you thinking about your cash generation capability with regard to those kind of looming litigation outflows? Ryan Preblick: Yes. Good question. Thanks. So certainly feel confident that, you know, as the business progresses, it's gonna generate strong cash flows year over year. We certainly do have to factor in these known obligations. There's the three of them. Right? There's the balance of the DOJ. That's spread, for the balance of the next two to three years. It and concluding in 02/1927. We settled a lot of the antitrust programs last year. So all that's remaining right now is $85 million for the opioid MDL that I mentioned. And then a small portion left of the Humana Centene when you look at it altogether, you know, some of those are in the on back end of it. And our growing business will generate strong cash moving forward. Paul Cuddon: Excellent. Thank you. Mark Crossley: Thank you, Paul. Operator: Thank you. This concludes today's question and answer session. I'll now hand the call back to Mark Crossley for closing remarks. Mark Crossley: Thank you, Heidi. And before I close the call, I'd like to add my thanks for your continuing interest in Indivior, our mission to make meaningful recovery from addiction humanly possible. Is as critical as ever. I look forward to the next exciting chapter for the company under Joe's leadership. Have any follow-up questions, please reach out to Jason and the IR team. Thank you very much, and have a great day. Operator: This concludes today's conference call. Thank you for participating. You may now disconnect. Where to invest $1,000 right now When our analyst team has a stock tip, it can pay to listen. After all, Stock Advisor's total average return is 829%* — a market-crushing outperformance compared to 155% for the S&P 500. They just revealed what they believe are the 10 best stocks for investors to buy right now, available when you join Stock Advisor. See the stocks » *Stock Advisor returns as of April 21, 2025 This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.
Yahoo
24-02-2025
- Health
- Yahoo
Indivior Announces FDA Approval of Label Changes for SUBLOCADE® (buprenorphine extended-release) Injection
Rapid Initiation Protocol Reduces Time to Treatment with SUBLOCADE® From One Week to One Hour, A Significant Advancement in the Treatment of Moderate to Severe Opioid Use Disorder (OUD) RICHMOND, Va., Feb. 24, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV), a global leader in addiction treatment, today announced that the U.S. Food and Drug Administration (FDA) has approved label changes for SUBLOCADE® including a rapid initiation protocol and alternative injection sites, marking a significant advancement in the treatment of moderate to severe opioid use disorder (OUD). Key Label Changes Include: Rapid initiation Protocol: Healthcare providers can now initiate treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability.1,2 Alternative Injection Sites: SUBLOCADE can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration2. These FDA label changes can provide important benefits for patients and healthcare providers. Rapid initiation may lessen some of the practical obstacles to treatment induction, which may increase the likelihood that patients and providers will start therapy quickly, thereby shortening the time to achieve SUBLOCADE's therapeutic levels that provide continuous buprenorphine concentrations above 2ng/mL.3 Additionally, the ability to select a different injection site may provide patients more flexibility so that they may be inclined to continue their treatment. More options for healthcare providers to administer SUBLOCADE will streamline the course of treatment and improve integration into different healthcare environments. "These label updates for SUBLOCADE underscore our dedication to evolving our treatment options to better serve individuals battling opioid use disorder," said Dr. Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. "These enhancements not only reflect our commitment to patient-centered care but also our ongoing efforts to align our treatments with real-world clinical needs, thereby potentially improving patient adherence and outcomes." Indivior is committed to empowering patients on their path to recovery by providing treatments that are both effective and tailored to their medical needs. These label changes do not alter the well-established safety profile or the efficacy of SUBLOCADE and the medication continues to offer an effective treatment option for OUD while being more adaptable to patient medical needs. The non-inferiority study supporting rapid induction with SUBLOCADE was conducted across multiple sites, included 729 participants (mean age 40.7, average opioid use of 15 years)1, and was stratified by fentanyl presence in urine screens. At induction 77.5% of patients were fentanyl-positive. Patients were randomized at a 2:1 ratio to rapid initiation [received a single dose of 4 mg transmucosal buprenorphine (TM-BUP), followed by a SUBLOCADE injection within one hour] or to a standard induction (daily TM-BUP over ≥7 days) before receiving injection 1. Rapid induction was effective, shown by the primary endpoint of participant retention at the second injection. The proportion of participants who received the second injection was 66.4% in the rapid induction arm and 54.5% in the standard induction arm2. About SUBLOCADE® SUBLOCADE ® (buprenorphine extended-release) injection, for subcutaneous use, CIII INDICATION AND HIGHLIGHTED SAFETY INFORMATION INDICATION SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. HIGHLIGHTED SAFETY INFORMATION WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program call the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements. CONTRAINDICATIONS Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE. WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE. Risk of Serious Injection Site Reactions: Likelihood of may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema and pruritus with some involving abscess, ulceration and necrosis. Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately. Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment. Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patients have tolerated transmucosal buprenorphine before injecting SUBLOCADE. Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. ADVERSE REACTIONS Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain. For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit About Opioid Use Disorder (OUD) Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences.4 OUD may affect the parts of the brain that are necessary for life-sustaining functions.4 About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit to learn more. Connect with Indivior on LinkedIn by visiting References Data on File. Indivior Inc. North Chesterfield, VA. SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use [package insert]. North Chesterfield, VA: Indivior PLC; 2025. Jones AK, Ngaimisi E, Gopalakrishnan M, Young MA, Laffont CM. Population Pharmacokinetics of a Monthly Buprenorphine Depot Injection for the Treatment of Opioid Use Disorder: A Combined Analysis of Phase II and Phase Ill Trials. Clin Pharmacokinet. 2021;60(4):527-540. doi:10.1007/s40262-020-00957-0. NIDA. 2022, March 22. Drugs and the Brain. Accessed October 30,2023, from View original content to download multimedia: SOURCE Indivior PLC
