Hematoma

MALVERN, Pa., Oct. 25, 2024 /PRNewswire/ -- Endo, Inc. 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 will be shared during SurgeWest, the 100th annual meeting of the Western Section of the American Urological Association (AUA), taking place October 27-November 1, 2024. "I'm pleased to share this medical knowledge to help healthcare providers think of Peyronie's disease phases in a different way than the current literature suggests, which may be serving to limit or postpone treatment options for patients suffering from the condition," said Dr. Jesse Mills, urologist and presenting author of the study. "The outcomes for patients both with and without pain suggest that CCH may be an alternative to watchful waiting, regardless of the phase of disease." 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; Gregory J. Kaufman, 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 painful 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 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 specialty 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. Mills 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, unfavorable safety or efficacy data; uncertainties in the regulatory approval process; compliance with regulatory obligations including those under the XIAFLEX REMS Program; unexpected litigation or other disputes; 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 such as those related to XIAFLEX®; the timing and uncertainty of the results of both the research and development and regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; the performance including the approval, introduction and consumer and physician acceptance of current and new products; the ability to develop and expand our product pipeline and to continue to develop the market for XIAFLEX® and other branded or unbranded products; the effectiveness of advertising and other promotional campaigns; and the timely and successful implementation of any strategic priorities. 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 Endo's press releases and in its 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. 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, Inc. 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10月16日，广东省疾病预防控制中心公布今年第41周（10月7日至13日）登革热疫情监测情况。全省新增报告2005例登革热病例。其中包含了4例重症。 早在2024年9月，广东省疾病预防控制局曾提醒称，今年以来，全球登革热疫情形势严峻。广东省在进入登革热流行季后，疫情传播风险逐步增高。 专家表示，登革热流行呈现季节性和周期性特点，目前，广东仍处于登革热流行季，或进入流行“大年”，需要引起警惕。 全球范围登革热高发 巴西卫生部当地时间10月15日公布的数据显示，今年以来，巴西登革热疑似及确诊病例上升至6547438例，死亡病例上升至5613例，另有1499名死亡病例待核查。 据广东省疾病预防控制中心网站信息，截至2024年8月底，全球已有80多个国家或地区报告了超过1000万例登革热病例和6000多例相关死亡病例，发病数为2023年同期的3倍。     当地时间10月16日，苏丹医生委员会发布报告称，苏丹中部城市恩图曼暴发登革热疫情，已造成253人死亡。巴西卫生部门表示，今年以来该国出现的登革热病例已远超去年全年约165万例的纪录。随着巴西北部和西部地区即将进入雨季，该国登革热病例数量有可能出现更大幅的上升。 病毒学专家常荣认为，相较于往年，今年报告的病例数量显著增加，这要归因于跨境旅游限制的放宽，导致人口流动更为频繁，进而在病例输入上呈现出显著差异。 “随着秋季的到来和气温的逐渐下降，伊蚊的活动能力和繁殖速度将逐渐减弱，这为登革热的防控工作提供了有利条件。据此评估，预计从11月开始，广东地区的登革热流行趋势将明显下降，病例数量逐步减少。”常荣山进一步指出。 常荣山判断，广东地区登革热的流行态势，亦与全球登革热疫情波动相关联，正赶上全球登革热流行周期的尾声阶段。 今年8月，国家卫生健康委印发了《登革热诊疗指南（2024年）》，进一步规范登革热临床诊疗工作。 流行病学 1、传染源 登革热患者、隐性感染者和带病毒的非人灵长类动物。 2、传播途径 主要通过伊蚊叮咬传播。在我国传播媒介主要为白纹伊蚊和埃及伊蚊。 3、易感人群 人群普遍易感，感染后部分人发病。登革病毒感染后，可对相同血清型病毒产生持久免疫力，但对不同血清型病毒感染不能形成有效保护。     临床表现 登革热临床表现复杂多样，潜伏期一般为1~14天，多为5~9天，病程可分为急性发热期、极期和恢复期。 1、急性发热期 此期一般持续3~7天。发热为首发症状，可伴畏寒。部分病例发热3~5天后体温降至正常，1~3天后再度上升，称为“双峰热”（也称“马鞍热”）。 发热时可伴头痛，全身肌肉、骨骼和关节疼痛，明显乏力，并可出现恶心、呕吐、腹痛及腹泻等消化道症状。 颜面四肢可见充血性皮疹或点状出血疹。典型皮疹为见于四肢的针尖样出血点及“皮岛”样表现（融合成片的红色斑疹，其中可见散在小片正常皮肤）。可出现皮下出血、注射部位瘀斑、牙龈出血、鼻衄等不同程度的出血现象，束臂试验可阳性。 2、极期 通常发生在病程4~8天。部分患者高热持续不退，或热退后病情加重，可出现腹部剧痛、持续呕吐、明显出血及血浆渗漏征等。 少数无明显皮肤黏膜水肿等表现的患者，仍可出现严重出血如皮下血肿、消化道出血、阴道出血、咯血、肉眼血尿、颅内出血等。 严重者可发生休克、弥漫性血管内凝血（DIC）和重要脏器损伤等并发症。少数患者可继发细菌或真菌感染。 3、恢复期 发热、胃肠道症状、出血等逐渐好转，皮疹消退，可有皮肤瘙痒。少数患者乏力等症状可持续数周甚至数月。     并发症 检查 诊断 1、疑似病例 发病前14天内曾到过登革热流行区，或居住地或工作场所周围1月内出现过登革热病例，符合登革热临床表现。 2、临床诊断病例     疑似病例血清标本登革病毒IgM抗体检测阳性或NS1抗原检测阳性。 3、确诊病例 疑似病例或临床诊断病例符合以下之一者： ①登革病毒核酸检测阳性； ②培养分离到登革病毒； ③血清登革病毒IgG抗体阳转或恢复期较急性期滴度呈4倍及以上升高。 重症登革热高危人群和早期预警指标 1、重症高危人群 ①年龄＞65 岁； ②晚期妊娠女性； ③有糖尿病、高血压、冠心病、消化性溃疡、慢性呼吸系统疾病、慢性肾病、慢性肝病和地中海贫血等基础疾病者； ④肥胖或严重营养不良者； ⑤二次感染者。 2、重症早期预警指标 （1）临床预警指标： 高热时间＞1 周或热退后病情加重，剧烈腹痛，频繁呕吐，鼻衄、牙龈出血、皮肤瘀斑等出血倾向，胸闷、心悸，呼吸困难，嗜睡、烦躁，皮肤巩膜黄染，尿量少于 0.5ml/（kg·h）。 （2）实验室预警指标： 发病早期血小板快速下降（＜50×109/L），低白蛋白血症（＜30g/L），肝酶、胆红素、心肌酶、脑钠肽、D-二聚体、乳酸等明显升高。     （3）影像学及心电图等预警指标： 浆膜腔积液、心律失常等。 登革热的治疗 以对症支持治疗为主，目前尚无有效抗病毒治疗药物。病例应采取防蚊隔离治疗，病程超过5天，且体温自然下降至正常超过24小时及以上可解除隔离。 1、一般治疗 （1）卧床休息，监测神志、生命体征、液体入量、尿量、血小板、红细胞压积、电解质等，极期患者密切监测重症早期预警指标。 （2）对血小板明显下降者，慎用有创检查，进行动静脉穿刺时要防止出血、血肿发生。 （3）避免盲目使用抗菌药物。继发细菌、真菌感染者，根据感染部位及可能的病原菌，经验性抗菌治疗，并根据微生物培养结果调整用药。 2、对症治疗 （1）以物理降温为主。高热不退者可使用对乙酰氨基酚等退热药物，避免使用阿司匹林。红细胞葡萄糖-6-磷酸脱氢酶缺乏症者应避免使用解热镇痛类药物，防止出现溶血。 （2）补液 轻症患者口服补液为主。适当进流质食物，对频繁呕吐、进食困难或血压低的患者，应及时静脉输液。 （3）镇静止痛 参考文献：登革热诊疗方案（2024年版） 撰文 | Anna.An 编辑 | Swagpp ● 震撼！坐车9小时去大三甲看病，医生下班了，睡在座椅下，副主任医师心疼加号！医生：不想被道德绑架，渴望有加号、退号和拒绝就诊的权力 ● 这8种饮食模式，延寿约4年！Nature子刊：华中科技大学揭秘，坚持这些饮食模式能降低慢病风险和死亡！哪种效果好？ ● 震撼！医生感慨：我们的工作量猛增，到手工资反而变少，真心扛不动了！医生两项工作量都在增加！我国住院率突破20%！为啥总喜欢住院呀 版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。 点击下方「阅读原文」 立刻下载梅斯医学APP！

MALVERN, Pa., Oct. 17, 2024 /PRNewswire/ -- Endo, Inc. ("Endo") (OTCQX: NDOI) announced today that seven 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 October 17-20, 2024. "I'm proud to be among those in the medical community who are investigating the common but under-studied condition of Peyronie's disease," said Matthew Ziegelmann, MD, urologist and presenting author of one of the podium presentations. "Armed with new insights and data, the healthcare providers attending SMSNA will be able to better support their patients through understanding and treatment methods." The seven Endo-sponsored and Endo-supported presentations are below: Sponsored by Endo: Podium presentation: A Noninterventional, Retrospective Multicenter Study to Evaluate CCH Treatment in Adult Male Participants With Ventral Curvature of the Penis Due to Peyronie's Disease Authors: Matthew J. Ziegelmann, MD; Majdee Islam, MD; Alexander J. Tatem, MD; Richard C. Bennett, MD; James Tursi, MD; David Hurley, MD; Gregory Kaufman, MD; Kristen Gumpf, PA-C; Jeffrey Andrews, MS; Tina Rezakhani, PharmD, MBA; Marian Ayad, PharmD, BCPS; Jesse N. Mills, MD Development of a Survey to Assess Women's Sexual Health Providers' Awareness and Approach Toward Peyronie's Disease and the Impact on the Female Sexual Partner Authors: Irwin Goldstein, MD; Sue W. Goldstein, CSE, CCRC, IF; Rose Hartzell, PhD; Tami Rowen, MD; Sameena Rahman, MD; Becky Lynn, MD; Alyse Kelly-Jones, MD; David Hurley, MD; Gregory Kaufman, MD; Lisa Bathish, BA, PMP; Nicole Tay, BS; Sheryl Kingsberg, PhD Peyronie's Disease Patient Journey: An Extensive Electronic Medical Record Analysis Authors: Jill Davis, MS; David Hurley, MD; Lorraine O'Donnell, MS, MBA; Nicholas Lazarou, MPH, MBA; Kristen Gumpf, PA-C; Larry Lipshultz, MD; Alexander Tatem, MD Investigator-Initiated Research: Podium presentation: Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial – 2 Year Outcomes Authors: Henry Larson, BS; Joshua Savage, PA-C; Klinton Brearton, CNP; Riley Warner, PA-C; Matthew Ziegelmann, MD; Sevann Helo, MD; Tobias Kohler, MD; Landon Trost, MD Podium presentation: Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie's Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study Authors: Jesse Labbe, BS; Joshua Savage, PA-C; Klinton Brearton, CNP; Riley Warner, PA-C; Matthew Ziegelmann, MD; Sevann Helo, MD; Tobias Kohler, MD; Landon Trost, MD Podium presentation: Efficacy and Safety of Collagenase Clostridium Histolyticum in Treating Primary Hourglass Deformities in Atypical Peyronie's Disease Patients Authors: Dyvon Walker, MD; Majdee Islam, MD Evaluating Practice Patterns of Clostridium Collagenase Histolyticum Providers Authors: Ranveer Vasdev; Niki Parikh; Michael Sischka, MD; Mattew Ziegelmann, MD 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 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 is a diversified specialty 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. Ziegelmann and any statements relating to product efficacy, clinical trials or studies, post-marketing experience, presentation of data, potential treatments or indications, therapeutic outcomes or treatment responses, safety or adverse reactions, 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 our current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which we may not currently be able to predict. Although we believe 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, unfavorable safety or efficacy data, preliminary data and trends that may not be predictive of future data or results, compliance with regulatory obligations including those under the XIAFLEX REMS Program, uncertainties and timing of the regulatory approval process, unexpected litigation or other disputes, our ability to successfully implement and execute on our strategies and initiatives, and changes in competitive, market or regulatory conditions. 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 Endo's press releases and in its 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. 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, Inc. 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