FDA
Differin Epiduo moves from Rx to OTC
Image source: Galderma
Acne treatment guidelines recommend combining a topical retinoid with benzoyl peroxide as a first-line approach for many patients, but access to prescription-strength combination therapy has often required a dermatology visit. FDA has now cleared Differin Epiduo Acne Gel (adapalene 0.1% and benzoyl peroxide 2.5%) for over-the-counter use in patients aged 12 years and older, expanding access to a guideline-supported acne regimen.
Differin Epiduo was previously available only by prescription and has been used by dermatologists for more than 15 years. The combination pairs adapalene, a third-generation retinoid developed to improve stability and tolerability, with benzoyl peroxide to target multiple drivers of acne, including follicular plugging, bacterial proliferation, and inflammation.
Clinical studies supporting the approval showed that the combination consistently outperformed adapalene alone, benzoyl peroxide alone, and vehicle gel across inflammatory and noninflammatory lesion counts as well as Investigator Global Assessment success rates. Improvement in inflammatory lesions was observed as early as week 1, with up to 70.3% reduction in inflammatory lesion counts at week 12.
Long-term studies also demonstrated sustained efficacy through 12 months of once-daily use. Investigators noted consistent efficacy and tolerability across diverse patient populations and skin tones.
The formulation uses a gel base designed to stabilize and distribute both active ingredients while maintaining benzoyl peroxide activity and improving tolerability. The product is administered once daily using a single-pump regimen.
“This milestone reflects a meaningful advancement for patients, as it expands access to a clinically proven, dual-active acne solution without the need for a prescription,” said Heather Woolery-Lloyd, MD, board-certified dermatologist. “In my practice, the combination of easy access and a simple, once-daily application can help patients use treatment more consistently in their treatment journey for the best possible outcomes.”
Source: Galderma. (2026, May 22). Press release. Galderma receives U.S. FDA approval for Differin Epiduo Acne Gel prescription-to-OTC switch