The fixed-dose adapalene 0.1% and benzoyl peroxide 2.5% topical OTC gel broadens nonprescription access to a combination topical regimen that has been used as a prescription product for more than 15 years.
Galderma recently announced that the
“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. 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,” 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 the news release.1
Galderma stated that the approval “expands access to a dermatologist-trusted, prescription-strength treatment for millions of acne sufferers ages 12 years and older.”1 For clinicians, the change may affect counseling around self-directed acne management, expectations for onset of response, irritation mitigation, and when patients should be referred for evaluation of more severe, scarring, or treatment-resistant disease.
Differin
The approval was supported by randomized, controlled phase 3 studies previously conducted for the adapalene/benzoyl peroxide fixed-dose combination, according to Galderma. 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, defined as “clear” or “almost clear.”1 Published clinical studies of the combination reported efficacy in acne vulgaris using once-daily topical application and included comparisons with monotherapies and vehicle.3,4
Galderma reported that lesion count improvement was observed as early as week 1 in the supporting program and that inflammatory lesion reduction reached up to 70.3% at week 12 in one cited study. The company also cited a single-arm long-term study in which approximately 65% total lesion reduction was maintained through 12 months. Tolerability was described as favorable across studied populations, including different skin tones.1
OTC availability may be clinically meaningful for adolescents and adults with mild to moderate acne who otherwise delay treatment or use less evidence-based regimens. However, OTC status also shifts more decision-making to patients and caregivers. Clinicians may need to reinforce that topical retinoid–benzoyl peroxide combinations can require consistent use over several weeks, may initially cause dryness or irritation, and should be integrated with gentle skin care and photoprotection when appropriate.2
The regulatory action applies to the US market. Galderma stated that Differin Epiduo will be available OTC at major retailers beginning in summer 2026 and noted that outside the US, Epiduo remains prescription only.1
From a practice standpoint, the switch does not eliminate the need for clinician-directed care. Patients with nodulocystic acne, scarring, postinflammatory dyspigmentation, substantial psychosocial burden, pregnancy-related treatment questions, or inadequate response to OTC therapy should still be evaluated. The main near-term change is access: a previously prescription fixed-dose retinoid/benzoyl peroxide regimen will be available without a prescription for eligible patients in the US.
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