Latest news with #XIAFLEX
Malaysian Reserve
4 days ago
- Health
- Malaysian Reserve
"Prime Time," a Branded Peyronie's Disease Commercial for XIAFLEX® (collagenase clostridium histolyticum)
The 90-second commercial builds on the 'Bent Carrot' campaign, launched in 2021, with creative that highlights a couple's journey from diagnosis to treatment. It spotlights the copay program designed to increase patient access and support a potential $0 out-of-pocket pathway for commercially insured patients. XIAFLEX is the only FDA-approved treatment for Peyronie's disease. DUBLIN, Aug. 12, 2025 /PRNewswire/ — Endo, a wholly-owned subsidiary of Mallinckrodt plc, announced today the launch of its XIAFLEX® (collagenase clostridium histolyticum or CCH) television commercial, Prime Time. The spot encourages men who may be experiencing Peyronie's disease (PD) symptoms to seek diagnosis and ask a urology specialist about XIAFLEX, the first and only FDA-approved nonsurgical treatment for PD. The campaign also spotlights the copay program designed to increase patient access, as ~94% of eligible commercially insured patients should pay $0 out of pocket for XIAFLEX.* The copay program is not available for government-insured patients. PD is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis. This curvature can be bothersome during arousal and intimacy.1 It is estimated that PD can affect as many as 1 in 10 men in the U.S.,2 but diagnosis rates remain low because men may be too uncomfortable to speak up and get help.3 'We're proud to continue our strong commitment to men's health and speak directly to men who may be worried about their Peyronie's disease symptoms,' said Justin Mattice, Senior Vice President & General Manager, Branded Specialty at Endo. 'With this campaign, we're urging men to speak with a urology specialist and explore whether XIAFLEX is right for them, while sharing information about common hesitations or misconceptions that might be holding them back.' Endo believes men should not suffer alone and aims to continue to help drive diagnosis improvement—both in the time it takes to seek a diagnosis and the number of people who are diagnosed. Do not receive XIAFLEX® if you have had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX®, or to any other collagenase product. Patient-Centric Campaign CreativePrime Time builds on Bent Carrot, the original branded commercial for XIAFLEX that debuted in 2021. This new campaign features creative and messages that highlight a couple's experience navigating the PD journey from symptom onset to treatment—including fears and hesitations they experienced along the way, as well as gratitude for the treatment outcome. The commercial opens with the couple watching television as the original Bent Carrot spot plays. The man reflects on his experience with PD and admits that embarrassment delayed his decision to seek help. Beside him, his partner offers encouragement and commends his decision to speak with a urology specialist. The couple also reflects on two hesitations that can deter PD patients: cost misinformation and fear of treatment. The commercial reinforces the copay program for XIAFLEX when the couple states that they ultimately paid nothing out of pocket, and they underscore the role of a trusted urology specialist who can explain the treatment side effects, process, and other information to help men and their partners make the decisions that are right for them. The commercial also includes the now familiar PD metaphor. During the spot, a bent carrot gradually straightens from 45 degrees to 26 degrees, symbolizing progress. The vegetable has been prominently featured in PD ads since the Bent Carrot launch four years ago. The campaign retains its call to action, Watch the commercial. Media BuyThe 90-second spot will air on streaming platforms and online video services like Prime Video, CBS, HBO Max, Hulu, and Peacock starting August 11. The commercial is also part of a larger surround-sound campaign that includes social media and digital ads on platforms where patients are active. About Peyronie's DiseasePeyronie's disease (PD) is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis. This curvature can be bothersome during arousal and intimacy.1 It is estimated that PD can affect as many as 1 in 10 men in the U.S.,2 but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help.3 IMPORTANT SAFETY INFORMATIONDo not receive XIAFLEX if: the Peyronie's plaque to be treated involves the 'tube' that your urine passes through (urethra). you are allergic to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX. XIAFLEX can cause serious side effects, including: 1. Penile fracture (corporal rupture) or other serious injury to the penis. Receiving an injection of XIAFLEX may cause damage to the tubes in your penis called the corpora. After treatment with XIAFLEX, one of these tubes may break during an erection. This is called a corporal rupture or penile fracture. This could require surgery to fix the damaged area. Damage to your penis might not get better after a corporal rupture. After treatment with XIAFLEX, blood vessels in your penis may also break, causing blood to collect under the skin (hematoma). This could require a procedure to drain the blood from under the skin. If a hematoma appears, skin and soft tissue necrosis (death of skin cells) may develop in that area, which could require surgery. After treatment with XIAFLEX, blood vessels in your penis may also break, causing blood to collect under the skin (hematoma). This could require a procedure to drain the blood from under the skin. If a hematoma appears, skin and soft tissue necrosis (death of skin cells) may develop in that area, which could require surgery. Symptoms of corporal rupture or other serious injury to your penis may include: a popping sound or sensation in an erect penis sudden loss of the ability to maintain an erection pain in your penis purple bruising and swelling of your penis difficulty urinating or blood in the urine a popping sound or sensation in an erect penis sudden loss of the ability to maintain an erection pain in your penis purple bruising and swelling of your penis difficulty urinating or blood in the urine Call your healthcare provider right away if you have any of the symptoms of corporal rupture or serious injury to the penis listed above. Do not have sex or any other sexual activity between the first and second injections of a treatment cycle. Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with XIAFLEX and after any pain and swelling has gone away. XIAFLEX for the treatment of Peyronie's disease is only available through a restricted program called the XIAFLEX Risk Evaluation and Mitigation Strategy (REMS) Program. 2. Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive XIAFLEX, because it contains foreign proteins. Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX: • hives • swollen face • breathing trouble • chest pain • low blood pressure • dizziness or fainting 3. Back pain reactions. After receiving an injection of XIAFLEX for Peyronie's disease, you may suddenly feel back pain, including severe lower back pain moving to your legs, feet, chest and arms. The back pain may also include spasms and make it hard to walk. These symptoms usually go away in 15 minutes or less, but may last longer. Tell your healthcare provider right away if you have sudden back pain, chest pain, or hard time walking after an injection. 4. Fainting. Fainting (passing out) or near fainting can happen in men who receive XIAFLEX, especially if they have severe penile pain. If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away. Before receiving XIAFLEX, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX injection, have a bleeding problem, received XIAFLEX for another condition, or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using XIAFLEX with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take medicines to thin your blood (anticoagulants). If you are told to stop taking a blood thinner before your XIAFLEX injection, your healthcare provider should tell you when to restart the blood thinner. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. What should I avoid while receiving XIAFLEX? Avoid situations that may cause you to strain your stomach (abdominal) muscles, such as straining during bowel movements. Do not use a vacuum erection device during your treatment with XIAFLEX. XIAFLEX can cause serious side effects, including increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX may not be right for you. The most common side effects with XIAFLEX for the treatment of Peyronie's disease include: a small collection of blood under the skin at the injection site (hematoma) swelling at the injection site or along your penis pain or tenderness at the injection site, along your penis and above your penis penis bruising itching of your penis or scrotum (genitals) painful erection erection problems (erectile dysfunction) changes in the color of the skin of your penis blisters at the injection site pain with sex a lump at the injection site (nodule) Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088. WHAT IS XIAFLEX? XIAFLEX is a prescription medicine used to treat adult men with Peyronie's disease who have a 'plaque' that can be felt and a curve in their penis greater than 30 degrees when treatment is started. It is not known if XIAFLEX is safe and effective in children under the age of 18. Rx Only Click for full Prescribing Information, including BOXED WARNING and Medication Guide. About EndoEndo, a wholly owned subsidiary of Mallinckrodt plc, is a diversified therapeutics manufacturer boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Statements Related To Forward-Looking StatementsThis release contains forward-looking statements, including with regard to XIAFLEX the potential of this product to improve health and treatment outcomes, and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of each of Endo's and Mallinckrodt's recent emergences from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with XIAFLEX; and other risks identified and described in more detail in the 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of Mallinckrodt's and Endo's most recent Annual Reports on Form 10-K, Mallinckrodt's Registration Statement on Form S-4, as amended, and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and we do not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. * Most eligible patients with commercial insurance plans should pay a $0 copay for XIAFLEX. Predictions based on historical analysis of claims filed September 2022 through August 2023. References Hellstrom WJ. Int J Impot Res. 2003;15:S91-S92. Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157. DiBenedetti DB, Nguyen D, Zografoset L, et al. Adv Urol. 2011:282503. ### Logo – View original content:
Associated Press
12-03-2025
- Health
- Associated Press
Endo Announces Peyronie's Disease Presentation at the Annual Meeting of the Southeastern Section of the American Urological Association
MALVERN, Pa., March 12, 2025 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today that a post hoc data analysis of a Phase 3 clinical trial of XIAFLEX® (collagenase clostridium histolyticum, or CCH) in patients with Peyronie's disease (PD) will be shared during the 89th annual meeting of the Southeastern Section of the American Urological Association (SESAUA), taking place March 12-15, 2025. 'I'm looking forward to sharing these medical insights to help healthcare providers reconsider how they approach the phases of Peyronie's disease, as current literature may be limiting or delaying treatment options,' said Dr. Gregory A. Broderick, urologist and presenting author of the study. 'The findings suggest that collagenase clostridium histolyticum could be a viable alternative to watchful waiting for patients regardless of their disease phase or pain status.' The Endo-supported research presentation is below: Peyronie's Disease Patients With Penile Pain at Baseline May Benefit From Collagenase Clostridium Histolyticum Treatment: A Post Hoc Analysis Authors: Jesse N. Mills, MD; Gregory A. Broderick, MD; James P. Tursi, MD; Marian Ayad, PharmD, BCPS; Tina Rezakhani, PharmD, MBA; Sajel Patel, PharmD; Jeffrey Andrews, MS; Landon Trost, MD About the Post Hoc Phase 3 Data Analysis1 A post hoc analysis of pooled data from two randomized, double-blind, placebo-controlled Phase 3 trials was conducted to evaluate CCH treatment and improvement in penile curvature in participants presenting with/without penile pain at baseline and disease duration of 12–18 months or >18 months. CCH-treated participants were stratified by the reporting of moderate-severe pain or no pain at baseline. Additional subgroup analyses stratified participants by presence of pain and disease duration (12–18 or >18 months). The primary efficacy endpoint was the percentage change in penile curvature at week 52 from baseline. Data support that there were no clear differences in CCH treatment outcomes between participants experiencing moderate-severe pain or no pain at baseline regardless of disease duration (12–18 versus >18 months). These analyses are consistent with other literature evaluating the efficacy of CCH in the acute phase of disease and suggest that ongoing pain is not a contraindication to CCH therapy. About Peyronie's Disease Peyronie's disease (PD) is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis. This curvature can be bothersome during arousal and intimacy.2 It is estimated that PD can affect as many as 1 in 10 men in the U.S.,3 but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help.4 About XIAFLEX® INDICATION XIAFLEX® is indicated for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. IMPORTANT SAFETY INFORMATION FOR XIAFLEX Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) XIAFLEX-treated patients in clinical studies. In other XIAFLEX-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or a penile 'popping' sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) XIAFLEX-treated patients. Signs or symptoms that may reflect serious penile injury should be promptly evaluated to assess for corporal rupture or severe penile hematoma which may require surgical intervention. Because of the risks of corporal rupture or other serious penile injury, XIAFLEX is available for the treatment of Peyronie's disease only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XIAFLEX REMS Program. Contraindications: XIAFLEX is contraindicated in the treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure and in patients with a history of hypersensitivity to XIAFLEX or to collagenase used in any other therapeutic application or application method Corporal Rupture or Other Serious Injury to the Penis: Injection of XIAFLEX into collagen-containing structures such as the corpora cavernosa of the penis may result in damage to those structures and possible injury such as corporal rupture (penile fracture). Therefore, XIAFLEX should be injected only into the Peyronie's plaque and care should be taken to avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or other collagen-containing structures of the penis. Cases of localized skin and soft tissue necrosis occurring as sequelae of penile hematoma, some requiring surgical intervention, have been reported post-marketing Hypersensitivity Reactions, Including Anaphylaxis: In the double-blind, placebo-controlled portions of the clinical trials in Peyronie's disease, a greater proportion of XIAFLEX-treated patients (4%) compared to placebo-treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 XIAFLEX injection procedures). The incidence of XIAFLEX- associated pruritus was similar after each injection regardless of the number of injections administered Because XIAFLEX contains foreign proteins, severe allergic reactions to XIAFLEX can occur. Anaphylaxis was reported in a post-marketing clinical trial in one patient who had previous exposure to XIAFLEX for the treatment of Dupuytren's contracture. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX injections. The safety of more than one treatment course of XIAFLEX is not known Risk of Bleeding in Patients with Abnormal Coagulation: In the XIAFLEX controlled trials in Peyronie's disease, 65.5% of XIAFLEX-treated patients developed penile hematoma, and 14.5% developed penile ecchymosis. Patients with abnormal coagulation (except for patients taking low-dose aspirin, eg, up to 150 mg per day) were excluded from participating in these studies. Therefore, the efficacy and safety of XIAFLEX in patients receiving anticoagulant medications (other than low-dose aspirin, eg, up to 150 mg per day) within 7 days prior to XIAFLEX administration is not known. In addition, it is recommended to avoid use of XIAFLEX in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low-dose aspirin) Acute Post-Injection Back Pain Reactions: Post approval reports of acute lower back pain reactions, sometimes accompanied by radiation to the lower extremities, chest and arms, muscle spasms, chest pain, paresthesias, headache, and dyspnea, have been received by patients treated with XIAFLEX for Peyronie's disease. These events can be mild to severe in intensity. The events typically lasted for 15 minutes and typically did not require intervention. Administer the smallest number of treatment cycles necessary to treat the patient's curvature deformity Adverse Reactions Clinical trials In the XIAFLEX clinical trials for Peyronie's disease, the most frequently reported adverse drug reactions (≥25%) and at an incidence greater than placebo included: penile hematoma, penile swelling, and penile pain. Post-marketing experience Acute post-injection lower back pain reactions have occurred in close temporal proximity to XIAFLEX treatments Cases of localized skin and soft tissue necrosis events as sequelae of penile hematoma, some of which required surgical intervention Syncope and presyncope have been reported in men treated with XIAFLEX for Peyronie's disease. Most, but not all cases occurred in the immediate treatment period or within 1-2 days following injection. Bodily injuries associated with the syncopal events have been reported Click for full Prescribing Information, including Boxed Warning and Medication Guide. About Endo Endo is a diversified pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Dr. Broderick and any statements relating to product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as 'believes,' 'expects,' 'anticipates,' 'intends,' 'estimates,' 'plan,' 'will,' 'may,' 'look forward,' 'intends,' 'guidance,' 'future,' 'potential' or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition; the timing and uncertainty of the results of the research and development and the regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation and other disputes; consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; the ability to develop and expand our product pipeline, to launch new products and to continue to develop the market for our products; and the effectiveness of advertising and other promotional campaigns. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading 'Risk Factors' in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. Gelbard M, Goldstein I, Hellstrom W, et al. J Urol. 2013;190(1):199-207. Hellstrom WJ. Int J Impot Res. 2003;15:S91-S92. Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157. DiBenedetti DB, Nguyen D, Zografoset L, et al. Adv Urol. 2011:282503.
