Fixed-Dose Combo Cream Treatment Approved for Acne Vulgaris

The FDA has approved tretinoin and benzoyl peroxide (Twyneo; Sol-Gel Technologies) cream, 0.1%/3%, for the treatment of acne vulgaris in individuals 9 years and older.

Tretinoin and benzoyl peroxide cream uses Sol-Gel’s technology to combine tretinoin, a retinoid, and benzoyl peroxide, within microcapsules. This allows the slow release of the active drug ingredients over time to provide safe and effective treatment.

The FDA approval of this medication emphasizes the ability to give access to innovative new important medications to the market, explained Dr Alon Seri-Levy, cofounder and chief executive officer of Sol-Gel Technologies. Based on the clinical data, tretinoin and benzoyl peroxide cream could change the treatment landscape for the millions of patients affected by acne. Tretinoin and benzoyl peroxide cream is significant because it combines 2 commonly used topical agents for acne treatment on the market. Tretinoin and benzoyl peroxide cream is the first FDA-approved fixed-dose combination of tretinoin and benzoyl peroxide.¹

“Due to stability issues, these products don’t play well together, and we were never able to recommend even consecutive coapplication of the 2 agents. Sol-Gel’s technology has solved this problem,” said Hilary Baldwin, MD, clinical associate professor of dermatology at Rutgers Robert Wood Johnson School of Medicine, medical director of The Acne Treatment and Research Center, and past president of the American Acne and Rosacea Society.

The new drug application (NDA) for tretinoin and benzoyl peroxide cream was approved by the FDA on July 26, 2021. The NDA was supported by positive results from 2 phase 3, randomized, double-blind, vehicle-controlled, multi-center studies, in which the treatment demonstrated efficacy and tolerability in patients with facial acne vulgaris. The most common adverse reactions have been reported as pain, dryness, exfoliation, erythema, dermatitis, pruritus, and irritation.

According to the American Academy of Dermatology, acne vulgaris affects up to 50 million people nationally. The disease emerges most often during childhood and adolescence, but it can also affect adults. Acne vulgaris patients suffer from inflamed or noninflamed lesions on areas of the body with a large concentration of oil glands, most often the face, chest, neck, and back.

“With market leader, Galderma, handling the product launch of Tywneo, we are excited that Twyneo will soon be available to patients in the US,” commented Dr Seri-Levy.

Reference

Sol-Gel Technologies Announces FDA Approval OF TWYNEO®. GlobeNewswire News Room. Sol-Gel Technologies Ltd; July 27, 2021. Accessed July 27, 2021. https://www.globenewswire.com/news-release/2021/07/27/2269561/0/en/Sol-Gel-Technologies-Announces-FDA-Approval-of-TWYNEO.html.