Adapalene Gel to Go OTC
Adults and adolescents with acne will have a new over the counter (OTC) treatment option. Adapalene gel (commercially known as Differin) received unanimous approval for OTC marketing by the Nonprescription Drugs Advisory Committee of the FDA. Adapalene, a third-generation topical retinoid, was first approved in 1996 as a prescription product. The 0.1% gel formulation is the most widely prescribed.
Galderma submitted four studies to help the committee reach a decision: a label comprehension study, a self-selection study, an actual-use trial, and a maximum-use trial. These studies examined whether or not patients understood label instructions and whether or not pregnant or breastfeeding women with acne would talk with a healthcare professional before using adapalene. In addition, the safety trials sought to determine the frequency of use and off-label use for conditions other than acne, to determine whether participants used the medication inappropriately near the eyes, mouth, lips, or on damaged skin, and to report any adverse effects.
The label instructions were well understood. Participants were able to follow the instructions regarding the frequency for use of adapalene and to not use it on damaged skin. The self-study showed that among pregnant women, 70% responded that they would consult a doctor before use. Reasons given for not contacting a provider before use was that women believed topical medications will not hurt a developing fetus, and that it is safe to use OTC products during pregnancy. Fifteen women said they did not see the warning on the label. Results of the actual-use trial showed that most participants used the product once daily to treat acne on the correct body area. There were no reports of serious adverse events.
Based on the results of these trials the Advisory Committee recommended OTC marketing, but suggested minor changes to label instructions and removal of the warning for pregnant or breastfeeding women.
Byline: Martha L. Sikes, MS, RPh, PA-C
Posted: May 6, 2016
Adapted from the original article.
[Image: Wikimedia/Roshu Bangal]