The newly approved product, which will be marketed as Twyneo, will utilize Sol-Gel's patented technology to entrap tretinoin—a retinoid—and benzoyl peroxide within silica-based microcapsules to stabilize tretinoin from being degraded by benzoyl peroxide and to slowly release each of the active drug ingredients over time to provide a favorable efficacy and safety profile.
The New Drug Application (NDA) for Twyneo was approved by the FDA on July 26, 2021. The NDA was based on positive results from two phase lll, randomized, double-blind, vehicle-controlled, multicenter studies in which Twyneo demonstrated efficacy and a favorable tolerability profile in adults and pediatric patients aged 9 years and older with facial acne vulgaris. The patent for Twyneo is protected until 2038. Sol-Gel, which partnered with Galderma to commercialize Twyneo in the United States, expects to receive a regulatory milestone payment in conjunction with this approval and retains the option to regain U.S. commercialization rights 5 years following first commercialization in the U.S.
The most common adverse drug reactions (incidence ≥1%) are pain, dryness, exfoliation, erythema, dermatitis, pruritus, and irritation (all at the application site). The use of this combination product is contraindicated in individuals with a history of serious hypersensitivity reactions to benzoyl peroxide or any other component of Twyneo.
In the press release, Dr. Alon Seri-Levy, cofounder and chief executive officer of Sol-Gel, stated, "The FDA approval of Twyneo underscores our ability to deliver innovative, proprietary drugs to the market. Based on the clinical data observed, we believe that Twyneo has the potential to change the treatment landscape for the tens of millions of patients suffering from acne vulgaris. With market leader, Galderma, handling the product launch of Twyneo, we are excited that Twyneo will soon be available to patients in the U.S."
Also in the press release, Hilary Baldwin, MD, clinical associate professor of dermatology, Rutgers Robert Wood Johnson School of Medicine; medical director, The Acne Treatment and Research Center; and past president of the American Acne and Rosacea Society, remarked, "Twyneo combines, for the first time, two of the most used topical agents available for the treatment of acne into a single application. Due to stability issues, these products don't play well together, and we were never able to recommend even consecutive co-application of the two agents. Sol-Gel's technology has solved this problem. The approval of Twyneo offers patients efficacy with these two products in a single convenient application. I believe physicians will look forward to adding Twyneo to their acne treatments toolbox."
For more information about Twyneo, visit https://www.sol-gel.com/downloads/twyneo-prescribing-information.pdf.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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