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FDA Approves Antibiotic-Free Treatment Option for Acne Patients

Once-daily adapalene/benzoyl peroxide gel scheduled for September launch

The FDA has given “thumbs up” to antibiotic-free Epiduo Forte (adapalene and benzoyl peroxide gel, 0.3%/2.5%, Galderma Laboratories) for the once-daily topical treatment of acne vulgaris.

Acne is the most common skin condition in the U.S., affecting more than 40 to 50 million people. Epiduo Forte gel is the first combination of 0.3% and 2.5% strengths of adapalene (a retinoid) and benzoyl peroxide, respectively, to be developed for patients with moderate-to-severe acne.

The agency’s approval was based on positive data from a pivotal phase III, 12-week, randomized, double-blind, vehicle-controlled study in which Epiduo Forte met each of its primary efficacy endpoints compared with vehicle gel in 217 subjects with acne.

The study demonstrated the superiority of Epiduo Forte Gel over 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 noninflammatory lesion counts.

In addition, 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.

More than half of the study subjects (50.5%) treated with Epiduo Forte gel reported a marked improvement in their severe acne.

The most commonly reported adverse events in patients treated with Epiduo Forte gel included skin irritation, eczema, atopic dermatitis, and a burning sensation.

Source: Galderma Laboratories; July 16, 2015.


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