Galderma Receives FDA Approval for Epiduo Forte for Acne

The FDA approved Galderma’s antibiotic-free Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5%, for the once-daily, topical treatment of acne vulgaris. 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 of Epiduo Forte Gel was based on a pivotal phase 3, 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 patients. The study demonstrated superiority of Epiduo Forte Gel 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 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 study subjects treated with Epiduo Forte Gel reported a marked improvement in their severe acne (50.5 percent).

“Acne is a challenging condition to manage. It can vary greatly from patient to patient, can have a significant physical and psychosocial impact on sufferers, and patients can find treatment adherence difficult to maintain,” said Jonathan Weiss, MD, a board certified dermatologist at Gwinnett Dermatology, P.C. and leading clinical investigator for the phase 3 trial of Epiduo Forte Gel. “For many patients, rapid results are especially important, and some acne treatments take time to show effect. We were very excited to see in the clinical trial that people using Epiduo Forte Gel saw results as early as one week, with efficacy continually improving through week 12.”

In the clinical trial, Epiduo Forte Gel was shown to be safe and well tolerated, and most adverse events (AEs) were mild to moderate in severity. The most commonly reported adverse events (≥1%) in patients treated with Epiduo Forte Gel were skin irritation, eczema, atopic dermatitis, and skin burning sensation. As an antibiotic-free acne treatment that was well tolerated in clinical trials, Epiduo Forte Gel can be considered for long-term use and offers convenience in a pump with once daily dosing. Epiduo Forte Gel will be available by prescription in early September 2015.

"As the industry leader in dermatology, Galderma recognizes the need for innovative acne medications across a spectrum of acne severities,” said Todd Zavodnick, President and General Manager of Galderma Laboratories, L.P. “The FDA approval of Epiduo Forte Gel has helped us expand on our robust acne franchise to deliver a safe, effective and antibiotic-free treatment to patients in need, and underscores Galderma’s continued commitment to skin health and antibiotic stewardship.”