Galderma announced that the Food and Drug Administration (FDA) has approved Epiduo Forte (adapalene and benzoyl peroxide) Gel 0.3%/2.5% for the once-daily topical treatment of acne vulgaris.

Epiduo Forte combines adapalene, a retinoid, and benzoyl peroxide, an antibacterial/keratolytic. Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. It acts as a modulator of cellular differentiation, keratinization and inflammatory processes. Benzoyl peroxide is an oxidizing agent with bacteriocidal and keratolytic effects.

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The FDA approval is based on data from a multicenter, randomized, double-blind, 12-week, vehicle-controlled Phase 3 study in 217 patients with acne vulgaris. Epiduo Forte demonstrated superiority to the vehicle gel in the overall study population (moderate-to-severe acne) at Week 12 for the Investigator’s Global Assessment Success Rate and for changes in inflammatory and non-inflammatory lesion count. More than half of study subjects treated with Epiduo Forte Gel reported a marked improvement in their severe acne and subjects who were “severe” at baseline (50%) were required to go from “severe” to “clear” or “almost clear” within the 12-week trial to be considered a treatment success.

Epiduo Forte Gel is antibiotic-free and will be offered in a pump with once-daily dosing. It is expected to launch in early September 2015.

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