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Endo Announces Positive Results From Phase 3 Studies Of CCH In Cellulite

Endo International plc (ENDP) announced positive results from two identical Phase 3 RELEASE studies of collagenase clostridium histolyticum or CCH for the treatment of cellulite in the buttocks.

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.

"Based on our review of the Phase 3 data, we remain confident in our CCH program for cellulite—a condition that makes many women self-conscious and prompts them to seek treatment options," said Matthew Davis, Endo's Senior Vice President and Chief Medical Officer. "If approved, CCH has the potential to be an important new treatment for cellulite and we are excited to take the next steps in that process."

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