New Prescription Acne Treatment Receives FDA Approval

The FDA today approved Galderma Laboratories’ antibiotic-free adapalene and benzoyl peroxide 0.3%/2.5% gel (Epiduo Forte Gel) for the once-daily treatment of acne vulgaris.

The agency based its nod on data from a phase 3 trial that evaluated the prescription drug’s efficacy in 217 participants with moderate to severe acne. At 12 weeks, Epiduo Forte Gel was deemed superior to vehicle gel in reducing inflammatory and non-inflammatory lesions, with more than 50% of patients with severe acne reporting a significant improvement in their condition.

“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 clinical investigator Jonathan Weiss, MD, in a press release. “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 1 week, with efficacy continually improving through week 12.”

The most commonly reported adverse events experienced by trial participants treated with Epiduo Forte Gel were skin irritation, eczema, atopic dermatitis, and skin burning sensation. Most of the side effects associated with the drug’s use were mild and moderate in severity, a finding that Galderma considers particularly relevant to acne patients with sensitive skin.

Galderma plans to launch Epiduo Forte Gel in early September 2015, according to a manufacturer press release.