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# Endo BLA for Treating Buttock Cellulite
- URL: https://www.fdaweb.com/endo-bla-for-treating-buttock-cellulite/
- Published: 2019-09-06T12:00:00.000Z
- Updated: 2026-09-15T01:48:09.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5144942

Endo International has submitted a BLA for collagenase clostridium histolyticum (CCH) for treating cellulite in the buttocks. The submission is based on data from two identical Phase 3 RELEASE studies that demonstrated a greater percentage of the 843 women treated during the studies met the primary endpoint of response with CCH versus placebo, according to the company. In addition, statistically significant improvements with CCH versus placebo were observed all eight (RELEASE-1) and seven of eight (RELEASE-2) secondary endpoints. The company says that most adverse events observed in CCH-treated patients were transient, mild/moderate and injection-site related (e.g., bruising, pain, induration, pruritus, erythema, and discoloration).