The FDA has approved Sol Ge's first proprietary drug product, TWYNEO (tretinoin/benzoyl peroxide) cream, 0.1%/3%, for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older. TWYNEO uses 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.

TWYNEO is patent protected until 2038. Sol-Gel has partnered with Galderma to commercialize TWYNEO in the U.S. Sol-Gel expects to receive a regulatory milestone payment in conjunction with this approval and retains the option to regain U.S. commercialization rights five years following first commercialization in the US.

“The FDA approval of TWYNEO underscores our ability to deliver innovative, proprietary drugs to the market,” says Dr. Alon Seri-Levy, Co-Founder and Chief Executive Officer of Sol-Gel, in a news release. “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 US. We remain focused on obtaining FDA approval of EPSOLAY® (benzoyl peroxide), our other Galderma-partnered product – the approval of which has been delayed due to FDA’s COVID-19-related restrictions. We are also making progress on our innovative earlier stage programs for erlotinib, roflumilast and tapinarof with the intent of advancing them into the clinic.”

“Galderma was founded forty years ago around a commitment to serve the dermatological needs of healthcare professionals and their patients,” says Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma. “Our heritage in acne dates back to our founding and we are excited to partner with Sol-Gel to bring yet another acne innovation to market for a condition that impacts up to 50 million Americans annually.”

“TWYNEO combines, for the first time, two of the most commonly 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,” explains 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. “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.”

The New Drug Application (NDA) for TWYNEO was approved by the FDA on July 26, 2021. The NDA was supported by positive results from two Phase 3, randomized, double-blind, vehicle-controlled, multi-center studies (NCT03761784, and NCT03761810), in which TWYNEO demonstrated efficacy and a favorable tolerability profile in subjects nine years of age and older with facial acne vulgaris. TWYNEO is the first FDA-approved fixed-dose combination of tretinoin and benzoyl peroxide.