FDA Greenlights First-Ever OTC Retinoid

July 7, 2016

The U.S. Food and Drug Administration (FDA) approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne in people 12 years of age and older. Differin Gel 0.1% is the first retinoid to be made available OTC for the treatment of acne, and contains the first new active ingredient for acne treatment for OTC use since the 1980s.

Differin Gel 0.1% was originally approved in 1996 as a prescription product for the treatment of acne vulgaris in patients 12 years of age and older.

Differin Gel’s safety and efficacy were initially established based on five clinical trials in people with mild-to-moderate acne. To support approval for OTC marketing, the data accrued from 1996-2016 on post-marketing safety, data from consumer studies and data from a maximal use trial were submitted.

Overall, results from the consumer studies showed that consumers can understand the information on the OTC label, appropriately select whether the product is right for them, and use the product appropriately. The maximal use trial, a study of absorption of the drug through acne-affected skin when applied daily over a large surface area, demonstrated that absorption is limited, thus supporting safe use of Differin Gel 0.1% by people using it OTC.

The drug should be applied once daily in a thin layer on the affected areas of skin, and it is for external use only. Differin Gel 0.1% should not be used on damaged skin People using Differin Gel 0.1% should avoid sunburn and avoid product contact with their eyes, lips and mouth. Women who are pregnant, planning to become pregnant, or breast-feeding should ask a doctor before use. While there have been no adequate and well-controlled studies of Differin Gel 0.1% in pregnant women, there is no specific evidence that Differin Gel 0.1%, when used topically as directed, causes birth defects in humans. Some other retinoid drugs have been shown to cause birth defects. Differin Gel 0.1% should not be used by people who are allergic to the product. In the first few weeks of use, skin may become irritated.

"This is great news for acne patients," says Judith Hellman, MD  a dermatologist in private practice in New York City and an associate professor in the Department of Dermatology at Mount Sinai Medical Center. "Differin gel is one of the most effective and well-tolerated retinoids and will also benefit patients who are seeking anti-aging remedies."

What's more, "the OTC price point will be important to make it accessible to those who need it," she says. There is no pricing available yet.

Up until this point, OTC acne treatments were limited to benzoyl peroxide, sulfur, and salicylic acid, adds Joshua Zeichner, MD, the Director of Cosmetic and Clinical Research in Dermatology at Mount Sinai Hospital in New York City. "Topical retinoids are a foundational treatment for acne in the office and for the first time a clinically proven topical retinoid will be available for OTC use. Ultimately, this will help improve therapeutic outcomes even for acne sufferers who don't have access to a dermatologist."

Differin Gel 0.1% is distributed by Galderma Laboratories, L.P., based in Fort Worth, Texas.


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