FDA approves Galderma’s Differin® Epiduo® Acne Gel (Adapalene 0.1% + Benzoyl Peroxide 2.5%) for OTC use in patients 12+, marking a major prescription-to-OTC milestone in acne care with strong clinical evidence and nationwide retail launch in summer 2026.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has approved Galderma’s Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5%) for over‑the‑counter (OTC) use in individuals aged 12 years and older. The decision marks a significant prescription‑to‑OTC transition in acne care, expanding patient access to a dermatologist‑trusted, prescription‑strength therapy backed by more than 15 years of clinical and real‑world use. The move aligns with FDA’s broader initiative to expand OTC availability of proven dermatology treatments.
First-in-Class Combination
Epiduo® was the first FDA‑approved fixed‑dose acne treatment to combine a topical retinoid with benzoyl peroxide in a stable formulation. The once‑daily gel pairs adapalene 0.1%, a third‑generation retinoid developed by Galderma, with benzoyl peroxide 2.5% to target multiple biological pathways of acne simultaneously. Galderma’s proprietary Simulgel™ Gel Base technology stabilizes and evenly distributes both actives, improving tolerability and supporting consistent patient use.
Clinical Evidence
More than ten Galderma‑sponsored studies involving over 3,200 patients, supplemented by third‑party research, demonstrated strong efficacy and tolerability. Key findings include:
- Improvement in acne lesions as early as Week 1
- Antimicrobial activity beginning Day 1
- 70.3% reduction in inflammatory lesions by Week 12
- Approximately 65% reduction in total lesions sustained through 12 months
- Consistent efficacy across diverse skin tones and patient populations
The combination gel consistently outperformed adapalene alone, benzoyl peroxide alone, and vehicle gel across inflammatory and non‑inflammatory lesion counts and Investigator Global Assessment success rates.
Expert Commentary
Bill Andriopoulos, President and General Manager of Galderma U.S., said the approval underscores Galderma’s leadership in acne and retinoid science. He noted that the adapalene‑benzoyl peroxide combination reflects dermatology guidelines recommending multimodal first‑line therapy while expanding OTC access without compromising effectiveness.
Heather Woolery‑Lloyd, MD, board‑certified dermatologist, added that OTC availability improves patient access to a clinically proven treatment and that the simple once‑daily regimen may support better adherence and outcomes.
Market Impact
Acne affects an estimated 50 million Americans annually, representing one of the most prevalent dermatological conditions. By removing the prescription barrier, Galderma positions Epiduo® to reach a broader patient base and strengthen its footprint in the U.S. acne treatment market.
Availability
Differin® Epiduo® Acne Gel will be available OTC across the United States beginning summer 2026 through major retailers including Walmart, Target, Ulta, and Amazon. Outside the U.S., Epiduo® will remain prescription‑only.
Reference
About the Writer
Chikkula Pavan Kumar (LinkedIn), PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.