First retinoid approved for over-the-counter use
The US FDA has approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne, for use in people 12 years of age and older
Differin Gel 0.1% is the first in a class of retinoids 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. The gel was originally approved in 1996 as a prescription product for the treatment of acne vulgaris in patients 12 years of age and older.
“Millions of consumers, from adolescents to adults, suffer from acne,” said Lesley Furlong, M.D., deputy director of the Office of New Drugs IV in the FDA’s Center for Drug Evaluation and Research. “Now, consumers have access to a new safe and effective over-the-counter option.”
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 (a label comprehension study, a self-selection study, and an actual use trial), and data from a maximal use trial were submitted.