The U.S. Food and Drug Administration (FDA) has approved Differin Gel 0.1% (adapalene) for over-the-counter (OTC) treatment of acne. FDA has not approved an OTC acne treatment ingredient in the last three decades and this once-a-day topical gel is the first-ever retinoid acne treatment approved for OTC use in the United States.
Prescription adapalene is currently approved in a variety of formulations, including a 0.1% solution, 0.1% lotion, 0.1% cream, 0.3% gel and 0.1% gel. It is also available as a topical gel in combination with benzoyl peroxide for treating acne in those aged 9 years and older. Differin Gel 0.1% was originally approved in 1996 for the treatment of acne vulgaris in consumers aged 12 and older.
In reviewing the application for the topical gel’s OTC use, FDA considered post-marketing safety data from 1996 to 2016, consumer studies and data from a maximal use trial. Galderma, the distributor of Differin Gel 0.1%, conducted three consumer studies, including a label comprehension study, a self-selector study in pregnant and lactating women and an actual use study.
Lesley Furlong, the deputy director of the Office of New Drugs IV in FDA’s Center for Drug Evaluation and Research, commented in a July 8, 2016, news release, “Millions of consumers, from adolescents to adults, suffer from acne. Now, consumers have access to a new safe and effective over-the-counter option.”
FDA approved the marketing of containers containing up to 45 grams of Differin Gel 0.1% with no more than two 45 gram tubes per package. The agency’s approval letter noted that “usage and exposure were key review issues” in evaluating the risks in “nonprescription marketing,” and that if Galderma wanted to market containers of more than 45 grams or package together more than two 45 gram tubes, the company should justify that in a subsequent application or request a pre-submission meeting.