Xiaflex (collagenase clostridium histolyticum) / Asahi Kasei, SOBI, Endo - LARVOL DELTA

Are patients undergoing intralesional collagenase Clostridium histolyticum injection therapy for Peyronie's disease compliant? A 7-year analysis from a tertiary care men's health center. (PubMed, J Sex Med) - "Overall compliance rate for CCH injection therapy was 70.89%. Greater curvature reduction was demonstrated in compliant patients. Common reasons for incomplete treatment included adverse effects (15.1%), early satisfaction with results (14.1%), and unknown factors (45.4%). However, missing data and bias from retrospective design are major limitations."

Journal • Pain

Response to Intralesional Collagenase Clostridium Histolyticum in Peyronie's Disease Patients with Concomitant Dupuytren's Contractures (AUA 2025) - "This study provides the first robust evidence that concomitant DC is associated with a superior response to CCH therapy in PD patients. The significantly greater curvature correction in the DC group suggests a potential synergistic effect of DC on CCH efficacy, meriting further investigation. These findings could influence clinical decision-making and patient counseling for men with PD and concurrent DC."

Clinical

Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie's Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study (AUA 2025) - P4 | "Men were randomized 3:1 to receive either CCH+traction (RestoreX)+sildenafil (treatment) up front or initial observation followed by treatment (controls). Repeating CCH using a novel protocol after an initially unsuccessful course of CCH achieves significant improvements in curvature and patient satisfaction. Additional data, including external validation, are warranted."

Clinical

Peyronie's disease outcomes following collagenase clostridium histolyticum may not differ by sexual orientation. (AUA 2025) - "In this series, patients who identified as MSM were with significantly higher rates of penile fracture following CCH. However, rates of complications requiring intervention, treatment satisfaction, and change in penile curvature were not statistically different in this population. While further work is needed to examine the use of CCH in this population, this data suggests that CCH may be used safely and with similar expected outcomes in the population of MSM."

Musculoskeletal Diseases

Efficacy And Safety Of Collagenase Clostridium Histolyticum Treatment In Patients With Complex Penile Plaques (AUA 2025) - "CCH injections significantly improved penile curvature in all plaque location groups, with no significant difference in the rate of most side effects between these five groups."

Clinical • Erectile Dysfunction • Musculoskeletal Diseases • Pain • Rheumatology

Injection therapy in the acute phase of Peyronie's disease: a systematic review of current evidence. (PubMed, J Sex Med) - "Injection therapy for the acute phase of PD demonstrates variable efficacy depending on the agent used and a relatively favorable safety profile; however, the overall quality of evidence remains low and is characterized by significant methodological limitations."

Journal • Pain

Comparative outcomes of intralesional collagenase injection for Peyronie's disease: acute vs. stable phase treatment. (PubMed, Int J Impot Res) - "Collagenase clostridium histolyticum (CCH) was FDA-approved for treating Peyronie's Disease (PD), demonstrating significant curvature improvement in patients during the stable phase of disease...A total of 55 patients (76.39%) in the stable phase and 23 patients (82.14%) in the acute phase showed improvement in curvature, with no significant differences in curvature outcomes or adverse events between the two groups. This study contributes to the growing evidence that intralesional CCH treatment during the acute phase of PD is safe and effective."

Journal • Pain

Mallinckrodt and Endo to Combine to Create a Global, Scaled, Diversified Pharmaceuticals Leader (PRNewswire) - "Mallinckrodt plc...and Endo, Inc...today announced that they have entered into a definitive agreement to combine in a stock and cash transaction to create a global, scaled, diversified pharmaceuticals leader...Mallinckrodt and Endo plan to combine their generic pharmaceuticals businesses and Endo's sterile injectables business after the close of the transaction and intend to separate that business from the combined company at a later date. Such a separation would be subject to approval by the combined company's Board of Directors and other conditions...The combined company's brands portfolio will comprise leading pharmaceutical brands across a range of therapeutic areas, including XIAFLEX (collagenase clostridium histolyticum), Acthar Gel (repository corticotropin injection), Terlivaz (terlipressin), SUPPRELIN LA (histrelin acetate) and AVEED (testosterone undecanoate)."

M&A • Ankylosing Spondylitis • Diabetic Nephropathy • Fibrosis • Immunology • Lupus • Multiple Sclerosis • Ocular Inflammation • Prostate Cancer • Psoriatic Arthritis • Renal Disease • Rheumatoid Arthritis • Sarcoidosis • Systemic Lupus Erythematosus • Uterine Leiomyoma

Endo Reports Fourth-Quarter and Full-Year 2024 Financial Results (Canada Newswire) - "XIAFLEX hit record revenues of $516 million in 2024, up 9% versus 2023."

Commercial • Fibrosis • Immunology • Uterine Leiomyoma • Women's Health

Endo Announces Peyronie’s Disease Presentation at the Annual Meeting of the Southeastern Section of the American Urological Association (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 (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."

Retrospective data • Sexual Disorders

Clinical Effectiveness of Splinting After Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture (AAOS 2025) - "Our study suggests greater benefit of night orthosis for PI P joint contractures. We recommend night orthosis after CCH treatment of PIP joint contractures and optional use for MCP contractures."

Clinical • Mood Disorders

Dupuytren's Contracture Interventions in the Medicare Population: A Ten-Year Analysis (AAOS 2025) - "There was a moderate increase in DC treatments within the Medicare population, with open fasciectomy remaining the most common intervention. Despite being discontinued elsewhere, collagenase clostridium histolyticum use drastically increased in the US. Additionally, there was a shift from hospital settings to clinics and offices, reflecting a trend towards more outpatient care."

Clinical • Medicare • Reimbursement • US reimbursement • Orthopedics

Analyzing the Impact of Collagenase Clostridium Histolyticum on Treatment Patterns and Social Deprivation Trends in Dupuytren's Contracture (AAOS 2025) - "Across different levels of social deprivation from 2013 to 2021, there was a notable variation in the utilizatio n patterns of treatments for Dupuytren's contracture, particularly an increase in fasciectomy use in communities with low social deprivation. This difference in practice among surgeons likely depended on several factors, some may include the socioeconomic status of patients and the available resources within the practice's zip code area. Previous literature analyzing provider trends before 2015 speculated that CCH would surpass surgical fasciectomy in utilization (Thayer et al., 2018)."

Clinical Effectiveness of an Orthosis After Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture. (PubMed, J Hand Surg Am) - "Our study suggests greater benefit of night orthosis for PIP joint contractures. We recommend night orthosis after CCH treatment of PIP joint contractures and optional use for MCP contractures."

Journal

Collagenase Clostridium Histolyticum Versus Percutaneous Needle Fasciotomy for Dupuytren's Disease: A Systematic Review and Meta-Analysis. (PubMed, Life (Basel)) - "While PNF showed fewer minor complications, overall clinical and patient-reported outcomes were comparable between the treatments. These findings highlight the need to tailor treatment choices to patient preferences and clinical context."

Journal • Retrospective data • Review • Dermatology • Pruritus

Efficacy of a Novel CCH Protocol for PD Among Prior Non-responders (clinicaltrials.gov) - P4 | N=40 | Active, not recruiting | Sponsor: Charitable Union for the Research and Education of Peyronie's Disease | Recruiting ➔ Active, not recruiting

Enrollment closed

Collagenase clostridium histolyticum for Dupuytren's disease: a comprehensive systematic review and comparative analysis against percutaneous needle aponeurotomy and limited fasciectomy. (PubMed, J Plast Surg Hand Surg) - "CCH demonstrates comparable efficacy to PNA; however, it may have a higher risk of local complications and recurrence compared to LF. Treatment decisions should be made on a case-by-case basis."

Clinical • Journal • Review • Pain

Contemporary nonsurgical management of Peyronie's disease. (PubMed, Curr Opin Urol) - "Herein, we will discuss notable advances in nonsurgical management of Peyronie's disease."

Clinical • Journal • Review • Urology • IFNA1

Therapy for Dupuytren's Disease (II): Collagenase Therapy vs. Limited Fasciectomy-A Long-Term Comparative Study. (PubMed, Life (Basel)) - "The two therapy options should be seen as complementary for the treatment of DD. Collagenase therapy seems a sensible option for DD with an earlier Tubiana stage and contractures that predominantly affect the MCP joint. Contractures with higher Tubiana stages that also affect the PIP joint should predominantly be treated with limited fasciectomy."

Journal • Fibrosis • Rheumatology • Solid Tumor

Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease (clinicaltrials.gov) - P4 | N=22 | Recruiting | Sponsor: University of Miami | Trial completion date: Jan 2025 ➔ Jan 2026 | Trial primary completion date: Jan 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Sexual Disorders

The case of a woman with bilateral Dupuytren's contractures who developed CRPS-1 after fasciectomy with no relapse on subsequent collagenase clostridium histolyticum injection and manipulation of the other hand: Considerations for implementing a Budapest criteria checklist and assessing vasomotor instability by measuring differences in skin temperature. (PubMed, J Hand Ther) - "Use of a BC checklist may guide documentation, speed recognition for an earlier diagnosis of CRPS in patients with Dupuytren's and an atypical post-fasciectomy response. Once identified, observed signs and measures of skin temperature could be used to monitor response to therapy and medical interventions. The positive outcome for this woman with Dupuytren's and CRPS-I after CCH injection are encouraging."

Journal • Musculoskeletal Pain • Neuralgia • Pain

An illustrated description of a modified collagenase Clostridium histolyticum protocol for Peyronie's disease. (PubMed, J Sex Med) - "The current manuscript provides a detailed narrative and illustrated description of our current CCH-administration technique."

Journal

Impact of Race and Ethnicity on Clinical Outcomes of Collagenase Clostridium histolyticum in Patients With Peyronie's Disease Across Kaiser Permanente Southern California Database. (PubMed, Perm J) - "The use of CCH treatment for PD is an effective option for racially diverse patient populations."

Clinical data • Journal

Collagenase injection versus limited fasciectomy surgery to treat Dupuytren's contracture in adult patients in the UK: DISC, a non-inferiority RCT and economic evaluation. (PubMed, Health Technol Assess) - "78. See the NIHR Funding and Awards website for further award information."

Clinical • Head-to-Head • HEOR • Journal • Surgery • Infectious Disease • Novel Coronavirus Disease

Impact of the Advent of Collagenase Clostridium histolyticum on the Surgical Management of Peyronie's Disease: A Population-Based Analysis. (PubMed, Perm J) - "This study illustrates that pentoxifylline is now more frequently used than colchicine and vitamin E as oral treatments for PD, while collagenase C. histolyticum injection therapy is now more prevalently employed than surgical intervention as the therapeutic approach for PD."

Journal • Erectile Dysfunction • Fibrosis • Pain • Rheumatology