New Prescription Acne Treatment Approved

The US Food and Drug Administration (FDA) has approved once-daily, topical antibiotic-free adapalene and benzoyl peroxide (Epiduo Forte Gel/ Galderma Laboratories) for the treatment of acne vulgaris.

The first combination treatment of retinoid, adapalene, and benzoyl peroxide, Epiduo Forte Gel received approval based on results from a pivotal phase 3, randomized, 12-week vehicle-controlled study involving a total of 217 acne patients.

The study met its primary endpoints — Epiduo Forte Gel was significantly more effective than placebo at the 12-week mark. Furthermore, the patients who were administered Epiduo Forte Gel reported a drastic improvement (50.5%) in their severe acne.

During the study most adverse events reported by participants were mild-to-moderate in severity, proving particularly important for those afflicted with sensitive skin. For example, the most commonly reported adverse events were skin irritation, eczema, atopic dermatitis, and skin burning sensation.

Jonathan Weiss, MD, board-certified dermatologist, Gwinnet Dermatology, PC, and the study’s leading clinical investigator, commented, “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. 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.”

Because this antibiotic-free acne treatment was well tolerated, Epiduo Forte Gel could be considered a potential treatment for long-term use.

The treatment is slated to be available by prescription in early September, 2015.