The FDA has approved antibiotic-free Epiduo Forte Gel, 0.3%/2.5%, for once-daily, topical treatment of acne vulgaris, according to a press release from Galderma.
Epiduo Fortel Gel is the first to combine the strengths of adapalene, a retinoid, and benzoyl peroxide for patients with moderate-to-severe acne, according to the release.
"Epiduo Forte Gel is an effective and well-tolerated antibiotic-free treatment option for the moderate to severe acne patient," Jonathan Weiss, MD, a board certified dermatologist at Gwinnett Dermatology, P.C. and a clinical investigator for the phase 3 trial of Epiduo Forte Gel, told Healio.com. "It contains the highest-available concentration of adapalene combined with benzoyl peroxide, which works by inhibition of excessive follicular keratinization and proinflammatory mediator release. Clinically, these actions lead to reduced erythema, swelling and inflammation and hence fewer papules and pustules, without the use of antibiotics."
The FDA approval was based on a phase 3, multicenter, randomized, double-blind, 12-week study in which primary efficacy endpoints were met when the gel was compared to vehicle gel in 217 patients with moderate-to-severe acne. In the study, Epiduo Forte Gel was rated superior over vehicle gel in the patients at week 12 for the Investigator’s Global Assessment Success Rate and for changes in inflammatory and non-inflammatory lesion count. Patients who were classified as having severe acne at baseline (50%) were required to go from “severe” to “clear” or “almost clear” within 12 weeks be considered a treatment success. There were 50.5% of patients treated with Epiduo Forte Gel who reported a marked improvement in their severe acne, according to the release.
Epiduo Forte Gel’s adverse events were mild to moderate in severity. Adverse events in at least 1% of patients included skin irritation, eczema, atopic dermatitis and skin burning sensation, the release stated.
"The FDA approval of Epiduo Forte Gel has helped us … deliver a safe, effective and antibiotic-free treatment to patients in need,” Todd Zavodnick, president and general manager of Galderma Laboratories, said in the release.
The product will be available by prescription in September, according to the release.