FDA Approves First-in-Class Switch of Adapalene

The FDA approved adapalene gel 0.1% (Differin Gel), a once-daily, over-the-counter, topical gel for the treatment of acne in people 12 years of age or older. This is a first-in-class switch. Originally approved in 1996 as a prescription product, Adapalene is the first retinoid approved for over-the-counter acne treatment. It contains the first new active ingredient for acne treatment for an over-the-counter product in over 20 years.

Adapelene’s safety and efficacy was based on 5 clinical trials in patients with mild to moderate acne. Results from consumer studies demonstrate a patients understanding of whether the product is the correct form of therapy for them.

On April 15, the FDA Nonprescription Drugs Advisory Committee (NDAC) voted 16-0 that adapalene gel 0.1%, the long-approved prescription topical retinoid for acne is safe for OTC use.

While the NDAC agreed that the safety profile and data for adapalene gel .01% were adequate to allow the product to be sold over-the-counter, the panel disagreed on appropriate labeling. The data was submitted by Galderma Laboratories, L.P. to support supplemental new drug application (sNDA) 20-380, for OTC marketing of adapalene gel 0.1% in patients 12 years and older. The issue of labeling was debated on several issues, including the use and safety in pregnant women and the additional labeling regarding photosensitivity.

The product approval comes with a warning that women who are pregnant, planning to become pregnant or breast-feeding should consult a doctor first as there are no adequate and well-controlled studies of adapelene gel in pregnant women. The FDA reports some retinoid drugs have been shown to cause birth defects. In addition, the labeling notes people using adapalene should avoid sunburn, and the product should avoid contact with their eyes, lips, and mouth. People may experience irritation over the first few weeks of use, and should consult a doctor if the irritation persists.