Highly Statistically Significant Results (P<0.001) Demonstrated on Primary Composite Endpoint and All Secondary Endpoints DUBLIN, Nov. 17, 2016 /PRNewswire/ — Endo International plc (NASDAQ / TSX: ENDP) announced today positive results from its Phase 2b study of collagenase clostridium histolyticum (or "CCH") for the treatment of edematous fibrosclerotic panniculopathy ("EFP"), commonly known as cellulite. CCH is known in its currently approved indications in the U.S. as XIAFLEX® for adult Dupuytren’s contracture and Peyronie’s disease. Trial subjects receiving CCH showed statistically significant levels of improvement in the appearance of cellulite with treatment, as measured by the trial’s primary endpoint (p<0.001), compared to those subjects receiving placebo. CCH was well-tolerated in the actively treated subjects with most adverse events (AEs) being mild to moderate in severity, and primarily limited to the local injection area. "We continue to be encouraged and very excited by the promising results of our CCH program, especially in the cellulite indication a condition which affects many millions of people," said Dr. Susan Hall, Executive Vice President, Chief Scientific Officer and Global Head of R&D at Endo. "We believe these data further reinforce our belief that CCH could be a potential treatment option for those with cellulite and we look forward to working with FDA to efficiently and effectively advance our development of the program into Phase 3." The Phase 2b trial enrolled 375 women with moderate or severe cellulite aged 18 years or older in the United States. Each subject received up to three treatment sessions of CCH (0.84 mg / session) or placebo with each treatment session occurring approximately 21 days apart. Twelve injections were administered into cellulite dimples during each session across an entire treatment quadrant left or right buttock or left or right posteriolateral thigh. At both the outset and conclusion of the study period (28 days after the last treatment), cellulite severity was assessed by each patient and clinician using two photonumeric cellulite severity scales developed by Endo and third-party experts. The scales the Photonumeric Cellulite Severity Scale (PCSS) are 5-point scales ranging from 0 (no cellulite) to 4 (severe cellulite) that measure improvement in the appearance of cellulite. The Phase 2b trial’s primary endpoint was the proportion of composite responders at Day 71 defined as subjects with a 2-point improvement in severity from baseline in the clinician-reported (CR) PCSS and a 2-point improvement in the patient-reported (PR) PCSS. Additional endpoints include a composite of 1-point responders, the percentage of responders with 1-point and 2-point improvements on the CR-PCSS and PR-PCSS, assessment of improvement by patient and clinician using the Global Aesthetic Improvement Scale (GAIS); subject satisfaction, and change in the Hexsel cellulite severity scale. "I believe these positive results demonstrate that CCH has the potential to be a treatment option for cellulite, a condition for which there are very limited safe and proven effective treatments," said Mitchel P. Goldman, MD, Medical Director, Cosmetic Laser Dermatology. "With so many millions of women affected by cellulite, there is a substantial need for new and innovative […]

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