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The FDA approved benzoyl peroxide 5% cream (Epsolay) for adults with inflammatory lesions of rosacea, on Monday.

Using silica-based microcapsules that create a barrier between the skin and the active ingredient, the topical is designed to slowly release "benzoyl peroxide over time to provide a favorable efficacy and safety profile," according to the manufacturer.

Support for approval came from two identical 12-week phase III trials that randomized a total of 733 adults with rosacea to either benzoyl peroxide or a vehicle solution.

The studies met their coprimary endpoints, with benzoyl peroxide-treated patients showing a 70% reduction in inflammatory lesions from baseline after 12 weeks of treatment, as compared to 38-46% for the group assigned to receive the vehicle without active ingredient.

And nearly half of the participants receiving active treatment were "clear" or "almost clear" of their inflammatory lesions (Investigator Global Assessment [IGA] score 0-1) at study end versus 38-46% of the vehicle participants.

During the open-label extension phase, which included 547 patients, 73% reached IGA 0-1 status at 1 year, and a post-hoc analysis showed speedy results with the treatment, with 2-week efficacy already favoring the benzoyl peroxide arm.

"There is poor adherence of my patients to current treatments for inflammatory rosacea and I look forward to being able to prescribe Epsolay to them," said dermatologist Neal Bhatia, MD, of Therapeutics Clinical Research in San Diego, in a statement from Sol-Gel's announcement. Bhatia cited rapid results and good tolerability with the product, "both of which are important factors to ensure patients' satisfaction."

Common adverse events seen with the topical were application site reactions, including pain and erythema (each in 2% of patients), as well as pruritis and edema (each in 1%). The agent also causes photosensitivity, so patients should be advised to avoid sun while using the treatment.

Sol-Gel also warned that contact dermatitis or skin irritation -- including scaling, dryness, stinging, or burning -- may occur and could necessitate discontinuation. Anaphylaxis and angioedema have also been reported with use of benzoyl peroxide products.

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