New topical agents for acne are rolling out

The Food and Drug Administration’s approval of adapalene gel 0.1 percent as an over-the-counter treatment for acne is a potential game changer that could lead to revision of guideline-recommended treatment algorithms.

In addition to discussing the implications of the FDA’s unprecedented approval of a full prescription-strength topical retinoid for OTC use, highlighted other developments in topical therapy for acne, including the 2016 approval of dapsone 7.5 percent gel, as well as several agents with novel mechanisms of action now ending their way through the developmental pipeline.

In announcing approval of adapalene gel 0.1 percent as an OTC product, the FDA cited as a major factor in the regulatory decision the opportunity to afford acne patients greater access to retinoid therapy. The drug is now on pharmacy and supermarket shelves, marketed by Galderma Laboratories under the brand name Differin gel 0.1 percent for once-daily application by patients aged 12 years and older at a cost $20-$28 for 45g.

This development could be very interesting from an access standpoint and in terms of how physicians write prescriptions for retinoids, in light of the co-pays for other agents.

We know that with other retinoids access is an issue. In Southern California, for example, we have strong pharmacy benefits managers for the insurance companies, and they’re very restrictive. It seems like every three months they change the pricing of the different retinoids. It’s something we have to work on to get out a fair price.

Dapsone gel, 7.5 percent, marketed as Aczone gel, 7.5 percent by Allergan, is a once-daily reformulation of the older 5 percent product administered twice daily. It received FDA approval for use in patients aged 12 years and older based on two 12-week, double-blind, placebo-controlled randomized trials totalling more than 4,300 acne patients. The studies showed the stronger once-daily product, compared with 21 percent of vehicle-treated controls.