Differin Gel 0.1 percent (adapalene) was approved as an over-the-counter (OTC) acne treatment by the U.S. Food and Drug Administration (FDA) last week, becoming the first retinoid acne mediation approved for OTC sales.
“Millions of consumers, from adolescents to adults, suffer from acne,” FDA Center for Drug Evaluation and Research, Office of New Drugs IV Deputy Director Dr. Lesley Furlong said. “Now, consumers have access to a new safe and effective over-the-counter option.”
Originally approved as a prescription drug to treat acne vulgaris in 1996, the FDA approved Differin Gel for OTC use after it reviewed data from 1996 to 2016. The first FDA approval of Differin Gel was based on five clinical trials that established its effectiveness against mild to moderate acne.
Acne affects approximately 50 million teens and adults in the U.S. Generally acne develops at puberty, but can linger into adulthood.
The skin disease forms pimples on the face, chest, back, neck and shoulders when hair follicles become clogged with dead skin cells and oil. Blackheads and whiteheads are also characteristics of acne. The disease can lead to poor self-esteem and depression.
Several prescription treatments and other OTC products are available to treat acne. The prescription products generally contain retinoids in oral or topical formulations, while topical OTC products may contain alpha hydroxyl acid, benzoyl peroxide or salicylic acid.
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