Latest news with #buprenorphine
Yahoo
19-06-2025
- Health
- Yahoo
Indivior Presents New Data at CPDD Demonstrating that High Buprenorphine Exposure May Improve Treatment Outcomes in High Fentanyl Users
A post-hoc analysis demonstrates that buprenorphine exposure with 300 mg SUBLOCADE® (buprenorphine extended-release) may improve treatment outcomes among opioid use disorder (OUD) patients with heavy fentanyl use1 Additional Indivior-funded research identified OUD treatment barriers in American Indian/Alaska Native (AI/AN) people who are often affected by higher drug overdose death rates compared to other racial and ethnic groups2-5 RICHMOND, Va., June 19, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq: INDV) presented new findings this week at the College on Problems of Drug Dependence (CPDD) Annual Scientific Meeting. A post hoc analysis showed that patients with heavier fentanyl use experienced clinically meaningful improvements in opioid abstinence when treated with a 300 mg maintenance dose of SUBLOCADE, compared to the 100 mg dose. While the 300 mg dose did not demonstrate a statistically significant advantage over 100 mg for weekly abstinence—the study's primary endpoint—in the overall population with moderate to severe opioid use disorder (OUD), the results suggest that higher doses of SUBLOCADE may offer better outcomes for individuals with high levels of fentanyl use. "These findings offer additional evidence that the higher maintenance dose of SUBLOCADE is safe and may better support patients with intense fentanyl use patterns," said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. "We aim to provide clinicians with new data that can transform treatment strategies and support patients on their journey to recovery." In the Indivior-funded study, patients with OUD who engaged in high-risk opioid use—such as injection use, high opioid dose consumption, or fentanyl use—received two initial 300 mg injections of SUBLOCADE one week apart. They were then randomized to receive eight monthly maintenance doses of either 100 mg or 300 mg. Both dosing regimens led to significant reductions in opioid use: the average weekly use dropped sharply from over 40 instances at screening to fewer than 3 by Week 3, and this improvement was sustained through Week 38. Notably, no new safety concerns were identified with either the 100 mg or 300 mg maintenance doses. Indivior also funded research exploring OUD treatment access and outcomes in American Indian/Alaska Native (AI/AN) populations, which were presented at CPDD. AI/AN populations experience disproportionate rates of OUD, drug overdose, and gap in access to OUD care. A thematic analysis of focus group research on nine AI/AN advocates indicated that AI/AN people experience significant barriers to accessing medication for opioid use disorder (MOUD).4-8 Barriers include stigma, institutional challenges, and transitions of care for OUD, highlighting opportunities for culturally appropriate interactive education and institutional advancement.2 These focus group findings are illustrative and can be used to identify avenues for future work, although they may not be generalizable to the full population. In addition, a large multi-year longitudinal claims database analysis of more than 75,000 AI/AN patients with evidence of OUD showed differences in utilization of MOUD among those seeing Indian Health Services (IHS) vs. non-IHS providers. The majority of patients (73.1%) saw non-IHS providers. Patients treated with any form of MOUD had lower all-cause emergency department vs. those who were not treated with MOUD, highlighting the need for further research to understand MOUD utilization among AI/AN. "The collective evidence from these presentations highlights prominent barriers to effective care and helps map out appropriate treatment approaches for individuals with OUD in challenging treatment settings," said Heidbreder. "Indivior focuses its scientific, treatment, and policy efforts on helping patients access the medications and support they need to recover." Key Abstracts Presented at CPDD: Higher Exposures with 300-Mg Buprenorphine Extended-Release (BUP-XR) Increased the Proportion of Responders Among Opioid Use Disorder (OUD) Patients with Heavy Fentanyl Use Barriers to and Facilitators of Medication Treatment for Opioid Use Disorder Identified by American Indian/Alaska Native Advocates Utilization of Medications for Opioid Use Disorder (MOUD) and Patient Profiles Amongst American Indian/Alaska Native Managing Opioid Use Disorder (OUD) Polysubstance Use in Treatment for Opioid Use Disorder: Opioid Abstinence and Alternative Substance Use Clinical Outcomes and Recovery in Adults with Opioid Use Disorder: Long-term Treatment with Long- acting Injectable Buprenorphine under Real-World Conditions Severity and Symptomatology of Opioid Use Disorder (OUD) Among Individuals Reporting Pain Reliever Use, Pain Reliever Misuse, and/or Heroin Use: A Cross-sectional Analysis of the 2021 and 2022 National Survey on Drug Use and Health Disclosure: This press release has been issued by Indivior Inc. and the content has not been approved or authorized by the College on Problems of Drug Dependence. 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. OUD may affect the parts of the brain that are necessary for life-sustaining functions. 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 Higher Exposures with 300-Mg Buprenorphine Extended-Release (BUP-XR) Increased the Proportion of Responders Among Opioid Use Disorder (OUD) Patients with Heavy Fentanyl Use [Late Breaking Oral Sessions]. CPDD Annual Scientific Meeting, June 15, 2025. Barriers To and Facilitators Of Medication Treatment for Opioid Use Disorder Identified by American Indian/Alaska Native Advocates [Oral Session: Expanding SUD interventions across populations]. CPDD Annual Scientific Meeting, June 17, 2025. Utilization of Medications for Opioid Use Disorder (MOUD) and Patient Profiles amongst American Indian/Alaska Native Managing Opioid Use Disorder (OUD) [Poster Session 1]. CPDD Annual Scientific Meeting, June 15, 2025. Indian Health Service. Disparities. 2019. Retrieved from Accessed: 16 May 2024. Centers for Disease Control and Prevention, National Center for Health Statistics (2024). Rate of National Drug Overdose Deaths, By Demographic. Available at: statistics/overdose-death-rates. Accessed: 6 Jun 2024. Soto C, et al. (2022). International Journal of Environmental Research and Public Health, 19(5), 2974. doi:10.3390/ijerph19052974 Krawczyk N, et al. . Drug Alcohol Depend. 2021 Mar 1;220:108512. doi: 10.1016/ Mpofu, E, et al.. (2021). Addictive Behaviors, 114, 106743. doi:10.1016/ View original content to download multimedia: SOURCE Indivior PLC Sign in to access your portfolio
Globe and Mail
16-06-2025
- Health
- Globe and Mail
Opioid Withdrawal Syndrome Market Insight, Epidemiology, and Market Forecast – 2034
Opioid Withdrawal Syndrome (OWS) is a major public health concern caused by the sudden reduction or cessation of opioids in dependent individuals. Symptoms like anxiety, cramps, and severe cravings make withdrawal a key barrier to recovery. With the ongoing opioid crisis, the demand for effective, accessible treatments continues to grow. DelveInsight's ' Opioid Withdrawal Syndrome Market Report ' offers a detailed analysis of the current and projected landscape for OWS treatment across the major markets, including the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. The report outlines the evolving epidemiology, highlighting the high prevalence of opioid dependence and withdrawal cases, particularly in countries severely impacted by opioid misuse. It also examines standard clinical practices and treatment gaps, providing a strategic overview of the healthcare burden and future market potential. Current treatment regimens for OWS typically involve a combination of opioid agonists such as buprenorphine and methadone, non-opioid medications like clonidine and lofexidine, and supportive symptom-based therapies. While effective to some extent, these approaches often face challenges related to tolerability, relapse risk, and access to care. The approval of non-opioid therapies like Lucemyra (lofexidine hydrochloride) has expanded options for managing withdrawal symptoms, but broader therapeutic innovation remains limited. Newer candidates in clinical development are targeting novel pathways to reduce withdrawal intensity and improve adherence during detoxification. With rising investments in addiction research, increasing awareness around opioid misuse, and supportive policy reforms in many countries, the OWS treatment market is set to evolve significantly by 2034. DelveInsight's report captures this transformation by evaluating market dynamics, key players, emerging therapies, and regulatory landscapes. It is an essential resource for pharmaceutical companies, healthcare providers, policymakers, and investors looking to understand and capitalize on the opportunities in this high-need therapeutic area. Some of the Key Facts of the Opioid Withdrawal Syndrome Market Report: • In 2022, the Opioid Withdrawal Syndrome market in the 7MM was valued at around USD 1.3 billion and is expected to grow steadily through 2034. • Approximately 8.2 million cases of opioid withdrawal syndrome were reported in the 7MM in 2022, with a projected decline over the forecast period. • Around 9.1 million individuals had long-term opioid use in the 7MM in 2022. • The US accounted for nearly 7.1 million opioid withdrawal cases in 2022, expected to decrease by 2034. • In March 2025, Hikma Pharmaceuticals announced that Health Canada approved KLOXXADO® (naloxone HCl) Nasal Spray 8 mg for the treatment of known or suspected opioid overdose, characterized by respiratory and/or central nervous system depression, in adult patients. • In February 2025, Indivior announced that the FDA approved label changes for SUBLOCADE® injection, a treatment for moderate to severe opioid use disorder (OUD). The updates include a rapid initiation protocol reducing treatment time from one week to one hour and alternative injection sites to improve flexibility and patient adherence. • In October 2024, the FDA approved Protega Pharmaceuticals' ROXYBOND™ (oxycodone IR 10 mg) for severe pain management. It is the first FDA-approved abuse-deterrent IR oxycodone designed to reduce intranasal and intravenous misuse. • Leading companies in the Opioid Withdrawal Syndrome market include atai Life Sciences, Medicinova, BioXcel Therapeutics Inc., and others. • Emerging acute Opioid Withdrawal Syndrome drugs include BXCL501, MN-166, DMX-1002, and others. • Opioid Withdrawal Syndrome remains a significant clinical challenge, with rising awareness and evolving treatment strategies driving demand for safer, more effective therapies to manage symptoms and reduce relapse risk. To know in detail about the Opioid Withdrawal Syndrome market outlook, drug uptake, treatment scenario, and epidemiology trends, click here: Opioid Withdrawal Syndrome Market Forecast Opioid Withdrawal Syndrome Overview Opioid Withdrawal Syndrome (OWS) is a clinical condition that occurs when individuals who are physically dependent on opioids suddenly reduce or discontinue their use. This syndrome is a hallmark of opioid dependence and is driven by the neuroadaptive changes in the brain that result from prolonged exposure to opioids. When opioid use is stopped, the abrupt absence of the drug leads to a rebound of neurotransmitter activity, particularly within the noradrenergic and dopaminergic systems, triggering a range of distressing physical and psychological symptoms. Symptoms of opioid withdrawal typically begin within hours of the last dose and can vary in intensity depending on the type of opioid used, duration of use, and individual factors such as tolerance and overall health. Common early symptoms include anxiety, agitation, muscle aches, sweating, and insomnia. These may progress to more severe manifestations such as abdominal cramps, vomiting, diarrhea, dilated pupils, rapid heartbeat, and intense cravings. While not usually life-threatening, the severity of symptoms can lead to significant discomfort and increase the risk of relapse. Get a free sample of the Opioid Withdrawal Syndrome market report with key insights and emerging therapies here: Opioid Withdrawal Syndrome Epidemiology The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends. Opioid Withdrawal Syndrome Epidemiology Segmentation: The Opioid Withdrawal Syndrome epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by: • Number of Opioid Misuse Cases • Number of Cases with long term Opioid usage • Total Opioid Withdrawal symptoms Cases Download the report to understand which factors are driving Opioid Withdrawal Syndrome epidemiology trends @ Opioid Withdrawal Syndrome Epidemiology Forecast Opioid Withdrawal Syndrome Drugs Uptake and Pipeline Development Activities The Opioid Withdrawal Syndrome drugs uptake section examines the rate at which newly launched or upcoming potential drugs are being adopted in the Opioid Withdrawal Syndrome market during the study period. This analysis covers drug uptake, patient adoption of therapies, and the sales performance of each drug. Additionally, the therapeutics assessment section highlights the drugs with the most rapid uptake, shedding light on the factors driving their widespread use. It also provides a comparative analysis of these drugs based on their market share. The report further delves into the Opioid Withdrawal Syndrome pipeline development activities, offering key insights into various therapeutic candidates in different stages of development and the major companies behind these innovations. It also covers recent collaborations, acquisitions, mergers, licensing agreements, patent details, and other critical information related to emerging therapies. Opioid Withdrawal Syndrome Market Outlook The Opioid Withdrawal Syndrome (OWS) market is expected to witness steady growth through 2034, driven by the increasing prevalence of opioid use disorder (OUD), rising awareness about withdrawal management, and expanding access to treatment services. As the opioid crisis continues to pose a significant public health burden across the globe, particularly in the United States and parts of Europe, the demand for effective withdrawal therapies is accelerating. The availability of both opioid-based and non-opioid pharmacological options, including buprenorphine and clonidine, is enhancing treatment outcomes and reducing relapse rates, contributing to market expansion. Furthermore, advancements in withdrawal management protocols, growing governmental and private sector investments in addiction care, and the development of more targeted and patient-friendly therapeutics are fueling innovation in the OWS treatment landscape. The emergence of new formulations, such as long-acting buprenorphine and novel non-opioid agents, is expected to diversify the treatment arsenal and improve patient adherence. With continued efforts toward destigmatization and the integration of mental health support, the OWS market is poised for sustained progress over the forecast period. Opioid Withdrawal Syndrome Market Strengths • Increased global awareness about the opioid crisis, coupled with supportive government policies, funding, and public health initiatives, has significantly strengthened the market. Programs promoting medication-assisted treatment (MAT) and opioid withdrawal management have expanded access to care, thereby boosting demand for therapeutic options. • The development of innovative pharmacological treatments, such as non-opioid medications (e.g., lofexidine) and extended-release formulations of buprenorphine, has improved treatment adherence and outcomes. These advancements enhance patient experience and create opportunities for differentiated products in the market. Opioid Withdrawal Syndrome Market Weaknesses • Despite increasing awareness, societal stigma associated with opioid dependence continues to prevent many individuals from seeking help. Underreporting and underdiagnosis of OWS limit the true market potential and delay access to treatment. • Despite increasing awareness, societal stigma associated with opioid dependence continues to prevent many individuals from seeking help. Underreporting and underdiagnosis of OWS limit the true market potential and delay access to treatment. Scope of the Opioid Withdrawal Syndrome Market Report • Study Period: 2020–2034 • Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] • Key Opioid Withdrawal Syndrome Companies: atai Life Sciences, Medicinova, BioXcel Therapeutics Inc., and others. • Key Opioid Withdrawal Syndrome Therapies: BXCL501, MN-166, DMX-1002, and others. • Opioid Withdrawal Syndrome Therapeutic Assessment: Opioid Withdrawal Syndrome, currently marketed, and Opioid Withdrawal Syndrome emerging therapies • Opioid Withdrawal Syndrome Market Dynamics: Opioid Withdrawal Syndrome market drivers and Opioid Withdrawal Syndrome market barriers • Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies • Opioid Withdrawal Syndrome Unmet Needs, KOL's views, Analyst's views, Opioid Withdrawal Syndrome Market Access and Reimbursement To learn more about the key players and advancements in the Opioid Withdrawal Syndrome treatment landscape, visit the Opioid Withdrawal Syndrome Market Analysis Report Table of Contents 1. Opioid Withdrawal Syndrome Market Report Introduction 2. Executive Summary for Opioid Withdrawal Syndrome 3. SWOT analysis of Opioid Withdrawal Syndrome 4. Opioid Withdrawal Syndrome Patient Share (%) Overview at a Glance 5. Opioid Withdrawal Syndrome Market Overview at a Glance 6. Opioid Withdrawal Syndrome Disease Background and Overview 7. Opioid Withdrawal Syndrome Epidemiology and Patient Population 8. Country-Specific Patient Population of Opioid Withdrawal Syndrome 9. Opioid Withdrawal Syndrome Current Treatment and Medical Practices 10. Opioid Withdrawal Syndrome Unmet Needs 11. Opioid Withdrawal Syndrome Emerging Therapies 12. Opioid Withdrawal Syndrome Market Outlook 13. Country-Wise Opioid Withdrawal Syndrome Market Analysis (2020–2034) 14. Opioid Withdrawal Syndrome Market Access and Reimbursement of Therapies 15. Opioid Withdrawal Syndrome Market Drivers 16. Opioid Withdrawal Syndrome Market Barriers 17. Opioid Withdrawal Syndrome Appendix 18. Opioid Withdrawal Syndrome Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Healthcare Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefit from market analysis to accelerate business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Contact Person: Jatin Vimal Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
