FDA Approves New Prescription Acne Treatment

Dermatologists and the more than 40 million Americans suffering from acne now have one more treatment option at hand. The U.S. Food and Drug Administration (FDA) has approved antibiotic-free Epiduo Forte Gel, 0.3%/2.5% for the topical treatment of acne vulgaris. The approval was based on a Phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled study, which included 217 patients with moderate to severe acne. Epiduo Forte Gel was found to be superior to the vehicle gel for the Investigator’s Global Assessment Success Rate and for changes in inflammatory and noninflammatory lesion count. Additionally, subjects who were “severe” at baseline (50 percent) were required to go from “severe” to “clear” or “almost clear” within the 12-week trial to be considered a treatment success—more than half of those treated with Epiduo Forte Gel reported a marked improvement in their severe acne (50.5 percent). Most adverse events were mild to moderate in severity—those most commonly reported (≥1 percent) were skin irritation, eczema, atopic dermatitis, and skin burning sensation.

Epiduo Forte Gel, which contains adapalene and benzoyl peroxide, will be available by prescription in early September.

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