Endo has announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.
The BLA is based on data from two identical, multicenter, double-blind, placebo-controlled phase 3 studies (RELEASE-1 and RELEASE-2) that evaluated the efficacy and safety of CCH in women aged 18 years and older with moderate to severe cellulite (N=843). Patients were randomized to receive up to 3 treatments of CCH or placebo approximately 21 days apart. The primary end point was a composite responder analysis measured by both the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) showing at least 2 levels of improvement in severity; key secondary end points included the proportion of PR-PCSS and CR-PCSS responders with ≥1- or ≥2-level improvements in the severity scale.
Results demonstrated a greater percentage of patients treated with CCH achieved the primary end point with statistically significant levels of improvement in the appearance of cellulite compared with placebo in both the RELEASE-1 (P =.006) and RELEASE-2 (P=.002) studies. Additionally, RELEASE-1 and RELEASE-2 showed statistically significant improvements in 8 out of 8 and 7 out of 8 key secondary end points, respectively; all validated patient-reported scales used in both studies also showed statistically significant improvements in the CCH group vs placebo.
Regarding safety, the most common treatment-emergent adverse events were transient, mild to moderate and injection-site related (eg, bruising, pain, induration, pruritus, erythema, and discoloration).
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