Adapalene and benzoyl peroxide Gel 0.3%/2.5%, (Epiduo Forte, Galderma), has received FDA approval for the once-daily, topical treatment of acne vulgaris. It is the first combination of these strengths of the retinoid, adapalene, and benzoyl peroxide, developed for the moderate to severe acne population.
The approval was based on a pivotal phase III, multicenter, randomized, double-blind, 12-week, vehicle-controlled study in which it met each of its primary efficacy endpoints when compared to vehicle gel in 217 acne subjects. The study demonstrated superiority of the adapalene and benzoyl peroxide gel 0.3%/2.5%, over vehicle gel in the overall study population (moderate to severe) at week 12 for the Investigator’s Global Assessment Success Rate and for changes in inflammatory and non-inflammatory lesion count.
Additionally, 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 study subjects treated with adapalene and benzoyl peroxide gel 0.3%/2.5% reported a marked improvement in their severe acne (50.5%).
In the clinical trial, adapalene and benzoyl peroxide gel 0.3%/2.5% was shown to be safe and well tolerated, and most adverse events (AEs) were mild to moderate in severity, which is important for acne patients with sensitive skin. The most commonly reported adverse events (≥1%) in patients treated with were skin irritation, eczema, atopic dermatitis and skin burning sensation. As an antibiotic-free acne treatment that was well tolerated in clinical trials, the gel can be considered for long-term use and is available in a pump with once daily dosing, according to Galderma. The gel will be available by prescription in early September 2015.
