Endo Announces Publication of Phase 3 Qwo (collagenase clostridium histolyticum-aaes) Data in Peer-Reviewed Dermatologic Surgery
DUBLIN, April 13, 2021 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today announced that Phase 3 data evaluating Qwo (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks of adult women was published in Dermatologic Surgery, the official journal of the American Society for Dermatologic Surgery. In addition to Phase 3 studies, the publication also includes a supplemental video that demonstrates the injection techniques for QWO.
The Phase 3 studies, conducted from February 2018 to September 2018, demonstrated that QWO provides a clinically meaningful improvement in the appearance of moderate to severe cellulite in the buttocks of adult women compared to placebo. QWO received FDA approval in July 2020 and is the first and only injectable treatment for moderate to severe cellulite in the buttocks of adult women.
"The data, from the largest cellulite studies ever conducted, provides further evidence that QWO may be an effective treatment for women with a variety of skin types who dislike the dimples on their buttocks," said Joely Kaufman-Janette, M.D., lead author, principal investigator and board-certified dermatologist at Skin Associates of South Florida.
The RELEASE-1 and RELEASE-2 Phase 3 studies, which were identically designed, randomized, double blinded and placebo-controlled, assessed the efficacy and safety of QWO for the treatment of cellulite in women. A greater percentage of the 843 women treated during the studies (QWO vs. placebo: RELEASE 1, n=210 vs n=213; RELEASE-2, n=214 vs n=206) met the primary endpoint of a composite 2-level response on a 5-point cellulite severity scale. Over half of the women treated with QWO in both studies met the secondary endpoint, a 1-level improvement in the patient reported assessment.
"The secondary endpoints in these studies reaffirm that many study participants and their doctors found that QWO delivered a clinically relevant improvement in the appearance of cellulite, and we are thrilled to have this data published in the peer-reviewed Dermatologic Surgery journal," said Ravi Tayi, M.D., M.P.H., Endo's Chief Medical Officer. "As we continue to train doctors on the use of QWO, we remain committed to sharing timely and relevant data with aesthetic healthcare practitioners."