FDA Approves First OTC Retinoid (Differin Gel 0.1%) for Acne

Troy Brown, RN


July 08, 2016

The US Food and Drug Administration (FDA) has approved the first over-the-counter (OTC) retinoid treatment for acne. Adapalene (Differin Gel 0.1%, Galderma Laboratories, LP) is applied once daily to the affected skin in patients aged 12 years and older.

Differin Gel 0.1% was first approved in 1996 as a prescription treatment for patients aged 12 years and older with acne vulgaris.

An FDA advisory committee recommended the approval of the OTC product in April.

"Millions of consumers, from adolescents to adults, suffer from acne," Lesley Furlong, MD, deputy director of the Office of New Drugs IV in the FDA's Center for Drug Evaluation and Research, said in a news release. "Now, consumers have access to a new safe and effective over-the-counter option."

There are currently several OTC and prescription medications for acne, but this is the first new active ingredient for OTC acne treatment since the 1980s.

Although topical retinoid products are often prescribed as first-line therapies for acne of all levels of severity, alone or in combination with other medications, Differin Gel 0.1% is the first retinoid that can be used alone or combined with other OTC treatments.

Women who are pregnant, who plan to become pregnant, or who are breast-feeding should talk with their doctor before using Differin Gel. There have been no adequate, well-controlled studies of Differin Gel 01% in pregnant women, but there is no specific proof that Differin Gel 0.1%, when used as directed, causes birth defects in humans. Some other retinoid drugs have been associated with birth defects.

The gel's approval was initially based on data from five clinical trials in patients with mild to moderate acne. For the OTC approval, researchers analyzed data accrued from 1996 to 2016 on postmarketing 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, according to the FDA.

The consumer study results overall showed that consumers are able to comprehend the information on the OTC label, select the correct dose for themselves, and select the appropriate product. The maximal use trial, a study of absorption of the drug through acne-affected skin when applied daily over a large surface area (face, shoulders, upper back, and chest), demonstrated that absorption is limited, thus supporting safe use of Differin Gel 0.1% by people using it OTC.

Consumers should follow the directions on the drug label exactly and should contact their healthcare provider if their symptoms fail to resolve. The drug should be applied once per day in a thin layer on affected skin only. It is for external use only and should not be used on sunburned or otherwise damaged skin. Patients should avoid sunburn when using this product and should not use it if they are allergic to any of the ingredients in the product.

Patients should discontinue use and contact their doctor if skin irritation becomes severe, no improvement occurs after 3 months of daily use, symptoms of allergic reaction appear, or they become pregnant or are planning to become pregnant while using the drug.

Retinoids include the active substances acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene, and tretinoin; they are taken by mouth or used as creams or gels to treat several skin conditions, including acne.

PRAC Review

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency announced today that it has begun a review of retinoids to study the current measures in place for pregnancy prevention and for reducing the possible risk for neuropsychiatric disorders.

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