Cellulite, or edematous fibrosclerotic panniculopathy, is a condition characterized by orange peel-like dimpling of the skin typically affecting the thighs and buttocks. It results from collagen fibrous septae held in an irregular pattern that causes skin dimpling and affects 85-98% of post-pubertal females. There are currently no FDA approved pharmaceutical therapies labeled for this indication.

In November 2016, Endo announced highly statistically significant top-line data from a Phase 2b study of XIAFLEX in patients with cellulite. The study enrolled 375 women, ages 18 years or older, with moderate or severe cellulite. Each subject received up to three treatment sessions of (0.84 mg/session) or placebo with a total of 12 injections per session, each occurring 21 days apart. The injections were administered into cellulite dimples during each session across an entire treatment quadrant - left or right buttock or left or right posterior thigh.

The primary endpoint was considered to be the portion of composite responders at Day 71 defined as patients 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.

The results demonstrated statistically significant levels of improvement in the appearance of cellulite (p<0.001) vs placebo. XIAFLEX subjects demonstrated a highly statistically significant improvement in composite investigators' and patients' assessments of appearance of cellulite as measured by one-point improvement in both CR-PCSS and the PR-PCSS scores (p-value of <0.001 vs placebo). A highly significant portion of the XIAFLEX subjects of this study reported being "Satisfied" or "Very Satisfied" with their treatment (p-value of <0.001 vs placebo), as well as being reported as "Improved/Very Improved/Very Much Improved" in global appearance of their given cellulite area as assessed by the subjects and investigators (p-value of <0.001 vs placebo). XIAFLEX was well-tolerated by all dose groups with most adverse events being mild-to-moderate and primarily limited to the local injection site.

Endo expects to initiate Phase 3 clinical trials of XIAFLEX for the treatment of cellulite in the coming months following FDA discussions.