Differin Gel (Adapalene Gel 0.1%) Wins FDA Approval for OTC Acne Use

First new active ingredient for OTC acne treatment in 30 years

The FDA has approved Differin gel 0.1% (adapalene, Galderma Laboratories), a once-daily topical gel for over-the-counter (OTC) treatment of individuals with acne. Differin gel 0.1% is approved for use in people 12 years of age and older.

Differin gel 0.1% is the first in a class of drugs known as 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. 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.

Acne is a common skin disease that affects approximately 50 million people in the United States. Acne pimples form when hair follicles of the skin clog up. Generally, pimples form on the face, neck, back, chest, and shoulders. Anyone can get acne, but it is most common in teenagers and young adults. Acne can cause scarring and have adverse psychological effects (for example, poor self-image, depression, and anxiety). Several OTC and prescription treatment options are available for people with acne.

Women who are pregnant, planning to become pregnant, or breast-feeding should ask a doctor before using OTC Differin gel. While topical retinoid products are often prescribed as first-line therapies for acne of all levels of severity, either alone or in combination with other treatments, Differin gel 0.1% is the first retinoid acne treatment to be made available OTC. 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.

The safety and efficacy of Differin gel were initially established based on the results of five clinical studies in subjects with mild-to-moderate acne. To support approval for OTC marketing, the data accrued from 1996 to 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 to the FDA.

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 (i.e., the face, shoulders, upper back, and chest), demonstrated that absorption is limited, thus supporting the safe use of Differin gel 0.1% by people using the product OTC.

Consumers should consult with their health care providers if their symptoms do not improve. 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 (for example, cuts, abrasions, eczema, or sunburn). People using Differin gel 0.1% should avoid sunburn and avoid product contact with their eyes, lips, and mouth. Differin gel 0.1% should not be used by people who are allergic to the product. In the first few weeks of use, the skin may become irritated (redness, itching, dryness, and/or burning). Consumers should stop use and consult a doctor if irritation becomes severe, if there is no improvement in acne after three months of daily use, if symptoms of allergic reaction appear, or if they become pregnant or are planning to become pregnant while using the drug.

Source: FDA; July 8, 2016.