Cellulite, or edematous fibrosclerotic panniculopathy, is a condition characterized by orange peel-like dimpling of the skin typically occurring mostly on the buttocks, thighs, lower abdomen and arms. Cellulite results primarily from the tethering of fibrous septae with fat cell volume as a secondary cause and affects 85-90% of post-pubertal women of all races. There are currently no FDA approved pharmaceutical therapies labeled for this indication.
The U.S. aesthetics market is a $15 billion growing market and U.S. aesthetics injectables is a $3.5 billion market and is growing more than 7% annually. According to the 2017 American Society for Dermatologic Surgery Consumer Survey, body sculpting is the #1 procedure that consumers are considering. Based on a survey conducted by Endo, over 70% of both dermatologists and plastic surgeons were either excited or extremely excited to potentially offer CCH for the treatment of cellulite as CCH potentially lyses the septae, releasing the dimple, permitting the skin to return to its normal contour.
In February 2018, Endo announced the initiation of two pivotal Phase 3 RELEASE clinical trials of CCH for the treatment of cellulite. These multicenter, randomized, double-blind, placebo-controlled studieds will evaluate the safety and efficacy of CCH in reducing the appearance of cellulite. These two U.S. studies are expected to enroll 840 women, 420 per trial, aged 18 years or older with moderate-to-severe buttock cellulite. Each subject will receive up to three treatments in which CCH, 0.84 mg per treatment area, or placebo will be administered. The two treatment areas include the left and right buttock. Each treatment visit will occur approximately 21 days apart. A total of 12 injections will be administered into cellulite dimples per treatment area per visit. Cellulite severity will be assessed at the beginning and conclusion of treatment. The assessments will be conducted by each patient and clinician using two validated photonumeric cellulite severity scales developed by Endo and third-party psychometric experts.
The primary endpoint of the studies is a composite responder analysis demonstrating at least a 2-level composite improvement on the photonumeric cellulite severity scale, independently reported by both the patient and clinician. Key secondary endpoints include the percentage of subjects that experience at least a 1-level or 2-level improvement in patient reported assessment, percentage of subjects with a 1-level composite improvement, percentage of satisfied subjects, change form baseline in a cellulite impact scale and the percentage of subjects with at least a 1-level or 2-level improvement in the global aesthetic improvement scale (GAIS).
In April, 2018, Endo presented clinical data from the Phase 2b study of CCH for the treatment of cellulite during the Premier Global Hot Topics session at the Annual Meeting of the American Society for Aesthetic Plastic Surgery (ASAPS). A statistically significant proportion of CCH subjects reported being "Satisfied" or "Very Satisfied" with their cellulite treatment compared to placebo subjects. CCH was also well-tolerated by all dose groups and most adverse events were mild to moderate, primarily limited to local injection area bruising (~75%) and pain (~59%). The data and the presentation demonstrated interest in the aesthetic community for innovative injectable treatment for patients with cellulite.
In the second quarter of 2018, Endo announced the completion of enrollment of the Phase 3 trials of CCH for the treatment of cellulite and expects to announce top-line results in the fourth quarter of 2018.