FORT WORTH, Texas — Galderma Laboratories has received Food and Drug Administration approval for antibiotic-free Epiduo Forte Gel (adapalene and benzoyl peroxide 0.3%/2.5%), a once-daily topical acne treatment.
Galderma said Thursday Epiduo Forte Gel is the first combination of 0.3%/2.5% strengths of the retinoid adapalene and benzoyl peroxide developed for the moderate to severe acne population. The product contains the highest concentration of adapalene, which works to unclog blocked pores and inhibits the release of proinflammatory mediators, to help stop acne from forming under the skin’s surface and decreasing the redness, swelling and inflammation associated with pimples, according to the company.
During a 12-week trial, patients who were “severe” at baseline (50%) were required to go from “severe” to “clear” or “almost clear” to be considered a treatment success. More than half of the study’s subjects treated with Epiduo Forte Gel reported a marked improvement in their severe acne (50.5%), Galderma said. For many patients, rapid results are important, and the clinical trial showed that patients using Epiduo Forte Gel saw results as early as one week, with efficacy continually improving through week 12, the company added.
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, Galderma said. The product is slated to become available by prescription in early September.
Acne is the most common skin condition in the United States, affecting more than 40 to 50 million people.
“Galderma recognizes the need for innovative acne medications across a spectrum of acne severities,” stated Todd Zavodnick, president and general manager of Galderma Labs. “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.”