FDA Approves First Prescription-to-OTC Switch for Adapalene-Benzoyl Peroxide Acne Gel
核心洞察
The U.S. FDA has approved Differin Epiduo (搜索) Acne Gel (adapalene 0.1% and benzoyl peroxide 2.5%) for over-the-counter use in patients aged 12 years and older, marking the first prescription-to-OTC transition for this combination therapy.
Clinical data from multiple Phase 3 studies demonstrated the combination gel consistently outperformed individual components alone, with up to 70.3% reduction in inflammatory acne lesions at Week 12 and sustained efficacy maintaining approximately 65% total lesion reduction through 12 months.
The approval expands access to a dermatologist-trusted treatment that combines a third-generation retinoid with benzoyl peroxide, addressing multiple biological drivers of acne through a once-daily regimen.
The U.S. Food and Drug Administration has approved Galderma's Differin Epiduo (搜索) Acne Gel (adapalene 0.1% and benzoyl peroxide 2.5%) for over-the-counter use in patients aged 12 years and older, marking a significant prescription-to-OTC transition in acne care. This approval represents the first time this stable, fixed-dose combination of a retinoid with benzoyl peroxide has become available without a prescription.
Clinical Foundation and Efficacy Data
The approval is supported by robust clinical evidence from multiple randomized, controlled Phase 3 studies involving over 3,200 patients. The combination gel consistently outperformed adapalene alone, benzoyl peroxide alone, and vehicle gel across inflammatory, non-inflammatory, and total acne lesions, as well as Investigator Global Assessment (IGA) success rates defined as "clear" or "almost clear."
Clinical data demonstrated clinically meaningful improvement in lesion counts as early as Week 1, with antimicrobial activity beginning on Day 1. At Week 12, patients achieved up to 70.3% reduction in inflammatory acne lesions. Long-term efficacy data showed sustained benefits, with approximately 65% total lesion reduction maintained through 12 months in a single-arm study, supporting once-daily, ongoing acne control.
The treatment demonstrated proven efficacy across diverse patient populations, with consistent results and favorable tolerability across different skin tones and a wide range of ages and acne severity levels.
Innovative Formulation Technology
Differin Epiduo (搜索) combines adapalene, a third-generation retinoid originally discovered and developed by Galderma, with benzoyl peroxide (0.1/2.5%). The adapalene molecule was specifically designed to address the stability and tolerability challenges of earlier retinoids, reflecting Galderma's leadership in retinoid science.
The formulation utilizes a proprietary Simulgel Gel Base that stabilizes and evenly distributes both active ingredients while maintaining benzoyl peroxide's efficacy and improving overall tolerability. This technology enables a simple, one-pump, once-daily regimen designed to support consistent treatment routines.
Together, the two active ingredients address key biological drivers of acne by clearing clogged pores, killing acne-causing bacteria, and reducing acne inflammation to help clear existing acne, prevent future breakouts, and improve skin tone, texture, and overall appearance.
Market Access and Clinical Legacy
First approved as a prescription treatment, Epiduo has been trusted by dermatologists for more than 15 years, with millions of prescriptions written worldwide. The product's global clinical legacy includes more than ten Galderma studies involving over 3,200 patients, along with extensive third-party studies.
Differin Epiduo (搜索) will be available over-the-counter at major retailers, including Walmart, Ulta, Target, and Amazon, beginning in summer 2026. The transition represents Galderma's integrated dermatology strategy, demonstrating how proven innovations from its therapeutic dermatology portfolio can strengthen its dermatological skincare offerings.
Regulatory Significance
This prescription-to-OTC switch expands access to a dermatologist-recommended, prescription-strength treatment for millions of acne sufferers. The approval highlights the depth of science behind the Differin and Epiduo heritage, backed by more than 15 years of real-world dermatologist use and a robust clinical research program.
Outside of the United States, Epiduo remains a prescription-only product. The U.S. approval represents a unique milestone in acne care, bringing proven prescription-strength science to a broader population through wider accessibility while maintaining the clinical efficacy established in the prescription setting.