Penile Induration

"PD Pool Hall" Explores the Men's Health Condition Through Real Patients and Real Talk Unscripted videos feature real Peyronie's disease (PD) patients discussing their experiences while shooting pool Though PD is a relatively common condition, diagnosis rates remain low because men with PD may be uncomfortable to speak up and get help "PD Pool Hall" videos are available online now and through digital and social advertising beginning in December DUBLIN, Nov. 30, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today the launch of its new branded video series, PD Pool Hall, which aims to educate people about Peyronie's disease (PD), a men's health condition that is estimated to affect 1 in 10 men in the U.S.* and can lead to a curvature deformity of the penis when erect. The PD Pool Hall videos feature four real patients, both treated and untreated, in a pool hall discussing their experiences with PD, including the impact on their lives and their treatment journeys. The conversations are unscripted and present the patients' actual views and stories. "The most knowledgeable person to talk to about Peyronie's is a specialized urologist, and the most relatable and empowering person is someone who has had PD themselves," said Justin Mattice, Vice President & General Manager, Branded Specialty at Endo. "The men in the videos know firsthand the confusion, embarrassment and even fear that men may face along the PD journey," Mattice continued. "Their authentic stories help to normalize the conversation around men's health and can motivate others who think that they may have PD to talk to a urologist about treatment options, including XIAFLEX® (collagenase clostridium histolyticum), the only FDA-approved nonsurgical treatment for PD." XIAFLEX should not be used if the Peyronie's plaque to be treated involves the urethra. The videos are viewable on Endo's newly redesigned consumer website for XIAFLEX, found at XIAFLEX.com. They will be used in digital and social advertising, beginning next month. * Based on a survey of about 7,700 U.S. adult men with a PD diagnosis, PD-related symptoms or a history of seeking treatment for the condition. 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 painful 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 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. IMPORTANT SAFETY INFORMATION Do 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. 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 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. 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-thecounter 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) Events of fainting (passing out) and near fainting have been reported by some patients treated with XIAFLEX. 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. Click for full Prescribing Information, including Boxed Warning and Medication Guide. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Mr. Mattice, any statements relating to product efficacy, 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 or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. References: Hellstrome 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, al. Adv Urol. 2011:282503 SOURCE Endo International plc

DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that five new presentations related to Peyronie's disease, or PD, and XIAFLEX® (collagenase clostridium histolyticum, or CCH, injection 0.9 mg) will be shared during the Sexual Medicine Society of North America (SMSNA) annual meeting, taking place November 16-19 in San Diego. "The relatively common condition of Peyronie's disease—estimated to affect 1 in 10 men in the U.S.—remains under-studied and is often misunderstood," said Dr. Jesse Mills, urologist and presenter of the data analysis poster. "Efforts like the post hoc analysis of XIAFLEX® Phase 3 data and the new landmark registry aim to advance medical knowledge of PD and support patient outcomes." The five new Endo-sponsored and Endo-supported presentations are below: Peyronie's Disease Patients with Penile Pain at Baseline Treated with Collagenase Clostridium Histolyticum: A Post Hoc Analysis Authors: Jesse N. Mills, MD; Gregory A. Broderick, MD; Gregory J. Kaufman, MD; James P. Tursi, MD; Marian Ayad, PharmD BCPS; Tina Rezakhani, PharmD MBA; Jeffrey Andrews, MS; Sajel Patel, PharmD; Landon Trost, MD Sponsored by Endo Clinical Understanding through Real-world data to Validate Effectiveness of treatments in Peyronie's Disease (CURVE-PD): Registry Design Authors: Jill Davis, MS; Jesse N. Mills, MD; Joshua Henderson; Marc Mason; Angel Cronin; Femida Gwadry-Sridhar, BSc Pharm, MSc (Epi), PhD; David Hurley, MD; Greg Kaufman, MD; Ranjith Ramasamy, MD; Mohit Khera, MD Sponsored by Endo Outcomes of Collagenase Clostridium Histolyticum in Men with Ventral Curvatures: An Updated Series Authors: Henry Larson, BSN; Joshua Savage, PA-C; Klinton Brearton, CNP; Riley Warner, PA-C; Matthew Ziegelmann, MD; Tobias Kohler, MD; Landon Trost, MD Publication grant provided by Endo Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie's Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study Authors: Bryce Palmer, BS; Joshua Savage, PA-C; Klinton Brearton, CNP; Riley Warner, PA-C; Matthew Ziegelmann, MD; Sevann Helo, MD; Tobias Kohler, MD; Landon Trost, MD Investigator-initiated research grant provided by Endo Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial – 1 Year Outcomes Authors: Henry Larson, BSN; Joshua Savage, PA-C; Klinton Brearton, CNP; Riley Warner, PA-C; Matthew Ziegelmann, MD; Sevann Helo, MD; Tobias Kohler, MD; Landon Trost, MD Investigator-initiated research grant provided by Endo 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 the CURVE-PD Registry CURVE-PD (NCT05873595) is a non-interventional study of up to 1,000 PD patients from 15 sites who have initiated treatment within two weeks before, at or any time after the date of enrollment. Patients will be followed for up to one year, and data will be collected from the patients, their healthcare providers and their partners. Patients will answer questions related to, but not limited to, reasons for treatment choice, self-measurement of curve before and after treatments; ability to participate in sexual activities before and after treatment; in-home stretching/modeling to complement in-office procedures; satisfaction, depression and anxiety scales, including the Peyronie's Disease Questionnaire (PDQ); and patient and partner satisfaction. Healthcare providers will answer questions related to, but not limited to, reasons for treatment choice, details of treatment, length and curve of penis before and after treatment and location of plaque treated. This registry will create the largest and most comprehensive collection of real-world PD data on treatment outcomes. 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 painful during arousal and intimacy.3 It is estimated that PD can affect as many as 1 in 10 men in the U.S.,4 but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help.5 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 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 (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Dr. Mills, any statements relating to product efficacy, 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 or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. References: Gelbard M, Goldstein I, Hellstrom W, et al. J Urol. 2013;190(1):199-207. Hellstrome 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, al. Adv Urol. 2011:282503 SOURCE Endo International plc

BALTIMORE, Sept. 7, 2023 /PRNewswire/ -- The American Urological Association (AUA) and the Urology Care Foundation (UCF), the world's leading nonprofit urological health foundation and official foundation of the AUA, are spreading awareness this September for Sexual Health Month. Sexual health can mean a variety of things and there are several urologic conditions that can affect a person's sexual health, such as erectile dysfunction, urinary tract infections, incontinence and more. Continue Reading American Urological Association (PRNewsFoto/American Urological Association) "Sexual health may be hard to talk about at times, but it's important to discuss any concerns you may have about your sexual function with your doctor. Your physician has expertise that can help you address problems that may be causing you distress," said Dr. Harris M. Nagler, President of the Urology Care Foundation. "There is a wealth of knowledge on the UCF website, and we suggest taking a moment to read these resources to show you may not be alone in sexual health deficiencies." Below are some of the sexual health resources available on the UCF website: Testicular Cancer Testosterone Therapy Erectile Dysfunction Premature Ejaculation Fertility Preservation and Gender Diverse Parenthood Adult Sexuality and Gender Diversity Adult Masculinizing Gender-Affirming Surgery Adult Feminizing Gender-Affirming Surgery Pelvic Floor Muscle Relaxing Vasectomy Peyronie's Disease or Curved Penis One issue with sexual health is that it is often not talked about because it can be considered 'embarrassing'. But having these conversations are vital for your overall health and wellness. Below is a list of common misconceptions that AUA urologists have encountered across in their practices. Testosterone deficiency is NOT the most common cause of erectile dysfunction; it's usually cardiovascular disease. Pain during sex is NEVER normal and is treatable. Erectile dysfunction is treatable, no matter the severity or duration. Sexual incontinence is common after prostate cancer treatment and is treatable. Having a vasectomy does not diminish testosterone or ability to have erections. What else can you do to support your sexual health? Some of the most valuable things you can do is to bring your partner with you to appointments, don't shy away from hard conversations, start with a doctor you feel close to and stay away from online chat groups or sources that are not credible. For more information and credible patient resources, visit UrologyHealth.org or ask your Urologist for more information. About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 22,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy. About the Urology Care Foundation: The Urology Care Foundation is the world's leading nonprofit urological health foundation, and the official foundation of the American Urological Association. Partnering with physicians, researchers, healthcare professionals, patients, caregivers, families and the public, the Foundation supports and improves urologic clinical care by funding research, developing patient education and pursuing philanthropic support. To learn more about the Urology Care Foundation and its programs visit: . Contact: Corey Del Bianco, Corporate Communications & Media Relations Manager 410-689-4033 [email protected] SOURCE American Urological Association and Urology Care Foundation