The FDA has approved Differin® Epiduo® Acne Gel (adapalene 0.1% and benzoyl peroxide 2.5%) for over-the-counter (OTC) use in patients aged 12 years and older with acne.
The prescription-to-OTC switch expands access to this combination topical regimen, which patients with acne have used as a prescription treatment for more than 15 years.
Meaningful Milestone
Differin Epiduo offers a dual-mechanism therapy that combines adapalene, a topical retinoid, with benzoyl peroxide to target comedogenesis, inflammatory lesions, and Cutibacterium acnes–associated activity. By aligning with guideline-endorsed foundational therapy for mild-to-moderate acne, the combination aims to address multiple contributors to acne pathogenesis providing the 50 million Americans who experience acne a reliable OTC treatment.
“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, a board-certified dermatologist and director of the Skin of Color Division for the University of Miami Department of Dermatology. “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.”
While the switch to OTC status broadens access for patients with acne, it does not eliminate the need for clinician-directed care. Professional evaluation remains a key element of the successful treatment of acne, especially in patients with the following symptoms and issues:
- Nodulocystic acne
- Scarring
- Post inflammatory dyspigmentation
- Substantial psychosocial burden
- Pregnancy-related treatment questions
- Inadequate response to OTC therapy
Study Details
Galderma stated that the approval of Differin Epiduo was supported by randomized, controlled phase 3 studies previously conducted for the adapalene/benzoyl peroxide fixed-dose combination. According to the findings, adapalene/benzoyl peroxide gel outperformed adapalene alone, benzoyl peroxide alone, and vehicle across inflammatory, noninflammatory, and total lesion counts, as well as Investigator Global Assessment success rates defined as “clear” or “almost clear.”
Published clinical studies evaluating once-daily topical application also demonstrated superior efficacy compared with monotherapies and vehicle treatment. Lesion count improvement was observed as early as week 1 in the supporting program, while inflammatory lesion reduction reached up to 70.3% at week 12 in one cited study.
The company also referenced a long-term study in which approximately 65% total lesion reduction was maintained through 12 months. Tolerability was reported as favorable across studied populations, including patients with different skin tones.
The regulatory action applies to the U.S. market, and Galderma has stated that Differin Epiduo will be available OTC at major retailers beginning in summer 2026, noting that outside the U.S., Epiduo remains prescription only.
Treatment Implications
The OTC availability of Differin Epiduo may benefit adolescents and adults with mild-to-moderate acne who might otherwise delay treatment or rely on less evidence-based regimens. However, OTC status also shifts more treatment decision-making to patients and caregivers, making clinician guidance on proper use especially important.
What Patients Should Know:
- Topical retinoid–benzoyl peroxide combinations can require consistent use over several weeks.
- Topical retinoid–benzoyl peroxide combinations may initially cause dryness or irritation.
- Topical retinoid–benzoyl peroxide combination should be integrated with gentle skin care and photoprotection when appropriate.
