FDA
25th May 2016

FDA Panel Gives Acne Treatment Two Thumbs Up

On April 15th, the FDA Nonprescription Drugs Advisory Committee (NDAC) voted unanimously in favor of the over-the-counter marketing (OTC) of adapalene gel 0.1% (Differin Gel, Galderma Laboratories) for the treatment of acne in people aged 12 years and older.

FDA Panel Gives Acne Treatment Two Thumbs Up

On April 15th, the FDA Nonprescription Drugs Advisory Committee (NDAC) voted unanimously in favor of the over-the-counter marketing (OTC) of adapalene gel 0.1% (Differin Gel, Galderma Laboratories) for the treatment of acne in people aged 12 years and older.

Adapalene is a third-generation topical retinoid that inhibits comedone formation and inflammation. In 1996, the FDA approved adapalene gel 0.1%, as a prescription product.

Since adapalene was previously approved by the FDA, the efficacy of the product was not discussed during this meeting; the product’s safety was the focus of discussion. While the committee voted 16-0 that the safety profile of adapalene gel 0.1% was sufficient to support marketing of the product in an OTC setting, the group was divided on the question of labeling.

The committee agreed that the warning about the use of adapalene while breastfeeding could be removed from the label, but had mixed views on whether to include a warning about its use during pregnancy. Some committee members stressed that inclusion of such a warning would be unnecessary if the panel truly believed the drug carried no risk for pregnant women; however, other members believed the warning should remain on the label.

Temporary voting committee member Sarah Gloria Obican, MD, Assistant Professor of Maternal Fetal Medicine in the Department of Obstetrics and Gynecology at the University of South Florida, Tampa stated, “we either say it’s safe or we say it’s not safe. If we voted that it’s safe, then I don’t like giving our pregnant moms misinformation…I want to be very, very clear to my patients.”

Similarly, voting committee member Paul Pisarik, MD, MPH, from St. John Health System Urgent Care, Tulsa, Oklahoma said, “if we think that it’s really safe like the data suggest that it is, I think we need to take that labeling off.”

In addition, some committee members suggested more specific labeling regarding sensitivity to sunlight and duration of use. Overall, the panel reached a consensus regarding the safety of adapalene, but not the labeling.

In the United States, acne is the most common skin condition, affecting as many as 50 million Americans annually. Acne can have significant physical and psychological effects, such as poor self-image, depression, anxiety and permanent scarring. The most common active ingredients, found in currently available OTC acne products include benzoyl peroxide, salicylic acid, alpha hydroxyl acids, and sulfur.

The agency is not obligated to follow its panel’s recommendation, but normally does so.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

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