Subjects receiving CCH showed highly statistically significant levels of improvement in the appearance of cellulite with treatment, as measured by the trial’s primary endpoint (RELEASE-1, p=0.006 & RELEASE-2, p=0.002), which was at least a 2-level composite improvement in cellulite severity in the target buttock at Day 71 as compared to subjects receiving placebo.
In addition, RELEASE-1 passed 8 out of 8 key secondary endpoints and RELEASE-2 passed 7 out of 8 key secondary endpoints. 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.
According to Matthew Davis, Senior Vice President and Chief Medical Officer for Endo, the company remains confident in its CCH program for cellulite. This likely indicates Endo will eventually seek FDA approval for the drug. This is exciting news for Endo heading into Thursday’s Q3 earnings report. Management previously intimated Xiaflex could disrupt the $15 billion aesthetics industry. Read more: