Endo Announces Peyronie's Disease Presentation at the Annual Meeting of the Southeastern Section of the American Urological Association
Endo (OTCQX: NDOI) has announced the presentation of a post hoc data analysis from a Phase 3 clinical trial of XIAFLEX® (collagenase clostridium histolyticum, or CCH) for Peyronie's disease at the 89th annual SESAUA meeting, March 12-15, 2025.
The analysis, presented by Dr. Gregory A. Broderick, suggests that CCH could be a viable alternative to watchful waiting for Peyronie's disease patients, regardless of their disease phase or pain status. The research specifically examines the potential benefits of CCH treatment in patients with penile pain at baseline.
The Endo-supported study involves multiple researchers, including specialists from various medical institutions, focusing on expanding treatment options for Peyronie's disease patients beyond current literature recommendations.
Endo (OTCQX: NDOI) ha annunciato la presentazione di un'analisi dei dati post hoc di uno studio clinico di fase 3 su XIAFLEX® (collagenasi clostridium histolyticum, o CCH) per la malattia di Peyronie durante il 89° incontro annuale della SESAUA, dal 12 al 15 marzo 2025.
L'analisi, presentata dal Dr. Gregory A. Broderick, suggerisce che il CCH potrebbe essere un'alternativa valida all'osservazione attenta per i pazienti affetti da malattia di Peyronie, indipendentemente dalla fase della malattia o dallo stato del dolore. La ricerca esamina specificamente i potenziali benefici del trattamento con CCH nei pazienti con dolore penieno alla baseline.
Lo studio supportato da Endo coinvolge più ricercatori, tra cui specialisti di diverse istituzioni mediche, con l'obiettivo di ampliare le opzioni di trattamento per i pazienti affetti da malattia di Peyronie oltre le attuali raccomandazioni della letteratura.
Endo (OTCQX: NDOI) ha anunciado la presentación de un análisis de datos post hoc de un ensayo clínico de fase 3 sobre XIAFLEX® (colagenasa clostridium histolyticum, o CCH) para la enfermedad de Peyronie en la 89ª reunión anual de SESAUA, del 12 al 15 de marzo de 2025.
El análisis, presentado por el Dr. Gregory A. Broderick, sugiere que el CCH podría ser una alternativa viable a la espera vigilante para los pacientes con enfermedad de Peyronie, independientemente de la fase de la enfermedad o del estado del dolor. La investigación examina específicamente los beneficios potenciales del tratamiento con CCH en pacientes con dolor peneano al inicio.
El estudio apoyado por Endo involucra a múltiples investigadores, incluidos especialistas de diversas instituciones médicas, centrándose en ampliar las opciones de tratamiento para los pacientes con enfermedad de Peyronie más allá de las recomendaciones actuales de la literatura.
Endo (OTCQX: NDOI)는 XIAFLEX® (콜라겐 분해 효소 클로스트리디움 히스토리티쿰, CCH)에 대한 3상 임상 시험의 후속 데이터 분석 결과를 페이로니병에 대해 발표했다고 2025년 3월 12일부터 15일까지 열리는 제89회 SESAUA 회의에서 발표했습니다.
그레고리 A. 브로더릭 박사가 발표한 이 분석은 CCH가 페이로니병 환자에게, 질병의 단계나 통증 상태에 관계없이 주의 깊은 관찰에 대한 실행 가능한 대안이 될 수 있음을 시사합니다. 연구는 특히 기준선에서 음경 통증이 있는 환자에 대한 CCH 치료의 잠재적 이점을 조사합니다.
Endo의 지원을 받는 이 연구에는 여러 연구자들이 참여하며, 다양한 의료 기관의 전문가들이 포함되어 현재 문헌의 권장 사항을 넘어 페이로니병 환자에 대한 치료 옵션을 확장하는 데 초점을 맞추고 있습니다.
Endo (OTCQX: NDOI) a annoncé la présentation d'une analyse de données post hoc d'un essai clinique de phase 3 sur XIAFLEX® (collagénase clostridium histolyticum, ou CCH) pour la maladie de Peyronie lors de la 89e réunion annuelle de la SESAUA, du 12 au 15 mars 2025.
L'analyse, présentée par le Dr Gregory A. Broderick, suggère que le CCH pourrait être une alternative viable à l'attente vigilante pour les patients atteints de la maladie de Peyronie, quelle que soit la phase de la maladie ou l'état de la douleur. La recherche examine spécifiquement les avantages potentiels du traitement par CCH chez les patients présentant des douleurs péniennes à la ligne de base.
L'étude soutenue par Endo implique plusieurs chercheurs, y compris des spécialistes de diverses institutions médicales, se concentrant sur l'élargissement des options de traitement pour les patients atteints de la maladie de Peyronie au-delà des recommandations actuelles de la littérature.
Endo (OTCQX: NDOI) hat die Präsentation einer post hoc Datenanalyse aus einer Phase-3-Studie zu XIAFLEX® (Collagenase Clostridium histolyticum, oder CCH) für Peyronie-Krankheit auf dem 89. jährlichen SESAUA-Meeting vom 12. bis 15. März 2025 angekündigt.
Die Analyse, die von Dr. Gregory A. Broderick präsentiert wurde, deutet darauf hin, dass CCH eine praktikable Alternative zum abwartenden Vorgehen für Patienten mit Peyronie-Krankheit sein könnte, unabhängig von der Krankheitsphase oder dem Schmerzstatus. Die Forschung untersucht insbesondere die potenziellen Vorteile der CCH-Behandlung bei Patienten mit anfänglichen Penis-Schmerzen.
Die von Endo unterstützte Studie umfasst mehrere Forscher, darunter Spezialisten aus verschiedenen medizinischen Institutionen, die darauf abzielen, die Behandlungsoptionen für Patienten mit Peyronie-Krankheit über die aktuellen Literaturempfehlungen hinaus zu erweitern.
- Potential expansion of XIAFLEX treatment eligibility to broader patient population
- New clinical data supporting alternative treatment approach to watchful waiting
- None.
"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
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
WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE'S DISEASE
Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (
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, and14.5% 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 www.endo.com 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
References:
- 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.
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SOURCE Endo, Inc.
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