Cancellation is due to concerns about the extent of bruising following initial treatment and prolonged skin discoloration.
Endo Aesthetics has announced the discontinuation of the production and sale of its collagenase clostridium histolyticum-aaes (Qwo) injection for the treatment of moderate to severe cellulite in the buttocks after industry concerns about the extent and variability of bruising after initial treatment and the potential for prolonged skin discoloration.
“Healthy skepticism should be welcomed and encouraged whenever we witness unsubstantiated claims within the aesthetic dermatology industry. To wit, as physician scientists, we have an obligation to only provide patients with scientifically valid information. For successful practices and trustworthy clinicians, rectitude, integrity, and ethics will continue to reign supreme,” said Will Kirby, DO, FAOCD, chief medical officer of LaserAway, and Editorial Advisory Board member of Dermatology Times®.
Endo Aesthetics has been working to address these concerns for the past year. In June 2022, Endo launched an open-label study, APHRODITE (NCT05419505), to test various interventions to see if they could help mitigate bruising. Some APHRODITE cohort’s results showed a moderate reduction of bruising area and severity, but none achieved a consistent level of reduced bruising after initiation treatment.
According to Endo Aesthetics, the decision to stop the production and sale of Qwo is expected to result in annualized pre-tax cash savings of approximately $50 million to $60 million and a reduction to Endo's global workforce of approximately 90 full-time positions. Regarding ceasing QWO production and sales, the Company expects to incur pre-tax cash restructuring charges of approximately $15 million to $20 million and record a total pre-tax restructuring charge of approximately $235 million to $250 million in the fourth quarter of 2022.
"Though the news is unfortunate, other colleagues have reported adverse events with the product. The clinical trials showing approximately 84% of subjects experiencing injection site bruising were also appreciated in the "real world" experience with the product. Patients want results with minimal adverse effects, mainly if they invest a lot of money in something they expect makes a significant difference. Perhaps in the future, we can see another product coming down the pipeline that can address moderate to severe cellulite in the buttocks of adult women, as it is a concern in many patients," said Renata Block, PA-C at Advanced Dermatology and Aesthetic Medicine and Dermatology Times® Editorial Advisory Board member.
Endo’s collagenase clostridium histolyticum-aaes injection remains approved by the US Food and Drug Administration with clinically proven results and an established safety profile, so practitioners may continue to use unexpired collagenase clostridium histolyticum-aaes injections that they have in stock, as well as order additional supply. Alternatively, practitioners can return unused collagenase clostridium histolyticum-aaes injections purchased before this announcement for a refund. Practices will be notified about these options.