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The FDA has approved a prescription-to-over the counter (OTC) switch for a topical combination adapalene-benzoyl peroxide product currently approved for acne in individuals aged 12 years and older, according to a press release from the manufacturer, Galderma.
The fixed-dose combination product, marketed as Differin Epiduo acne gel (adapalene 0.1% and benzoyl peroxide 2.5%) was approved as a prescription acne treatment in December 2008 for patients aged 12 years and older.
Multiple phase 3 studies have found that that this combination treatment was superior to each ingredient alone on several clinically meaningful endpoints, according to the press release. They include a 2009 study of 1670 individuals with acne, which found the combination used once a day was significantly more effective in treating acne compared with either ingredient alone or vehicle at 12 weeks.
Epiduo Forte, a higher-strength version with 0.3% adapalene and 2.5% benzoyl peroxide, was approved for prescription use in July 2015 and remains a prescription-only product.
The OTC product will be available over the counter in the United States in the summer of 2026, but it currently remains prescription-only outside of the US, according to Galderma.
