FDA approves Epiduo Forte (adapalene and benzoyl peroxide gel) to treat acne- Galderma

Galderma Laboratories announced that the FDA approved antibiotic-free Epiduo Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5%, for the once-daily, topical treatment of acne vulgaris. Acne is the most common skin condition in the United States, affecting more than 40 to 50 million people. Epiduo Forte Gel 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 Phase III, multicentre, 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. 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 those treated with Epiduo Forte Gel reported a marked improvement in their severe acne (50.5%). Most adverse events were mild to moderate in severity; those most commonly reported (up to 1%) were skin irritation, eczema, atopic dermatitis and skin burning sensation.

Comment: Long-term use of antibiotics in acne treatments may be a contributing factor to the overall global antibiotic resistance issue. Propionibacterium acnes (P. acnes), a bacterium linked to acne, is increasingly becoming resistant to topical and oral antibiotics, which may potentially cause a decrease in treatment efficacy against acne.