Cellulite

On September 6, 2019, our partner Endo announced that it filed its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for CCH for the treatment of cellulite.

The BLA submission included positive top-line data from two pivotal Phase 3 clinical trials, RELEASE-1 and RELEASE-2, of CCH for the treatment of cellulite with additional data presented in May and June 2019. Both RELEASE-1 (p=0.006) and RELEASE-2 (p=0.002) achieved the primary endpoint of composite responder analysis demonstrating at least a 2-level composite improvement of cellulite appearance independently reported by patients and clinician on the photonumeric scales of cellulite severity. Key secondary endpoints included both investigator and patient assessments of cellulite appearance as measured by CR-PCSS (Clinician Reported- Photonumeric Cellulite Severity Scale) and PR-PCSS (Patient Reported- Photonumeric Cellulite Severity Scale) scores, SSRS (Subject Self Rating Scale) and the Subject-Global Aesthetic Improvement Scale. Eight out of eight key secondary endpoints were achieved for RELEASE-1 and seven out of eight were achieved for RELEASE-2. CCH was well tolerated in actively treated subjects with most adverse events being mild to moderated and limited to the local injection area.

Cellulite