First injectable for moderate to severe cellulite approved by FDA
Earlier this month Endo International received US Food and Drug Administration (FDA) approval of Qwo™ (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks of adult women. QWO is the first FDA-approved injectable treatment for cellulite.
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.
“[The] FDA approval of QWO is a key achievement in the continued execution of Endo’s long-term strategy, especially as it relates to building our portfolio and capabilities for the future,” said Blaise Coleman, President and Chief Executive Officer of Endo. “As Endo embarks on an exciting new journey into medical aesthetics, we look forward to bringing this innovative treatment to market through our Endo Aesthetics organization.”
While cellulite is known to be a multifactorial condition, a primary contributing factor is the fibrous connective tissue, called the “fibrous septae,” which connect the skin perpendicularly to the fascia below.2,3 These fibrous septae tether the skin, drawing it downward and leading to a mattress-like appearance, commonly referred to as “dimpling.”4,5 When injected into the treatment area, QWO is thought to release the fibrous septae enzymatically by specifically targeting Types 1 and 3 collagen, which may result in smoothing of the skin and an improved appearance of cellulite.
“Endo recognized a significant unmet need for an effective and non-invasive injectable treatment for cellulite, which led us to conduct the largest clinical trials in the history of cellulite investigation in the United States,” said Matthew Davis, M.D., R.Ph., Senior Vice President and Chief Medical Officer of Endo. “Supported by rigorous research, testing and development processes, we are proud to have received FDA approval of the first injectable treatment for cellulite in the buttocks and we look forward to delivering QWO to the aesthetics community and their adult female patients.”
Side effects of QWO included injection site bruising, pain, areas of hardness and itching in the treatment area. Please see Important Safety Information below for more details.
“QWO could be a game-changer for many women with cellulite,” said Anne Chapas, M.D., a board-certified dermatologist at Union Square Laser Dermatology in New York City. “I am thrilled there will now be an FDA-approved injectable treatment option proven to address a root cause of cellulite. What is exciting about QWO is that it is a cutting-edge cellulite treatment, without the cutting.”