The Food and Drug Administration (FDA) has approved Qwo™ (collagenase clostridium histolyticum-aaes; Endo International) for the treatment of moderate to severe cellulite in the buttocks of adult women.
The approval was based on data from 2 identical, multicenter, double-blind, placebo-controlled phase 3 studies (RELEASE-1 and RELEASE-2) that evaluated the efficacy and safety of Qwo in women aged ≥18 years with moderate to severe cellulite (N=843). Patients were randomized to receive up to 3 treatments of Qwo or placebo at 21-day intervals.
The primary end point of the study was the proportion of 2-level multicomponent responders at Day 71 post randomization defined as at least 2 levels of improvement in cellulite severity from baseline on both the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS).
Results from both studies showed treatment with Qwo was associated with greater reductions in cellulite severity compared with placebo as measured by CR-PCSS and PR-PCSS scales at day 71. Additionally, both studies showed that treatment with Qwo led to greater improvement in the measure of patient-reported satisfaction compared with placebo.
With regard to safety, the most common adverse reactions were related to the injection site (bruising, pain, nodule, pruritus, erythema, discoloration, swelling, and warmth). Qwo must not be substituted for other injectable collagenase products and it is not indicated for the treatment of Peyronie disease or Dupuytren contracture.
The Company expects to launch Qwo in Spring 2021. The product will be supplied as a preservative-free lyophilized powder in single-dose vials (0.92mg and 1.84mg of collagenase clostridium histolyticum-aaesfor) for subcutaneous use.
For more information visit qwo.com.