FDA Approves Topical Acne Treatment Dapsone (Aczone)

Product will be available in May

Allergan has received approval from the FDA to market dapsone gel, 7.5% (Aczone, Allergan), a topical sulfone for the treatment of acne vulgaris in patients 12 years of age and older. The product may be used to treat both inflammatory and noninflammatory acne in a once-daily application.

The safety and efficacy of dapsone gel, 7.5%, were evaluated in two identically designed 12-week, randomized, double-blind, vehicle-controlled studies. A total of 4,340 acne patients were randomly assigned to receive either dapsone gel, 7.5% (n = 2,162) or vehicle (n = 2,178). Most of the patients (99%; n = 4,339) had moderate acne, with a baseline score of 3 on the Global Acne Assessment Score (GAAS). Dapsone gel, 7.5%, was approved by the FDA based on coprimary endpoints of the GAAS and lesion counts (20 to 50 inflammatory lesions and 30 to 100 noninflammatory lesions at baseline) in these trials.

At week 12, dapsone reduced inflammatory lesions by 15.8 lesions (54.6%; n = 2,162) compared with 13.9 lesions (48.1%; n = 2,178) with vehicle, and noninflammatory lesions were reduced by 20.7 lesions (45.1%) compared with 18.0 lesions (39.4%), respectively. The GAAS success rate in patients treated with dapsone was 29.8% (n = 2,162) compared with 21.1% with vehicle (n = 2,178).

In addition to efficacy, dapsone gel, 7.5%, demonstrated a favorable tolerability profile. Out of 2,161 patients who used the gel, 1.1% experienced mild application-site dryness compared with 1.0% of those treated with vehicle (n = 2,175), and 0.9% experienced pruritus compared with 0.5%, respectively.

The mechanism of action of dapsone gel, 7.5%, in treating acne vulgaris is not known.

The product will be available in the U.S. in May 2016.

Sources: Allergan; February 25, 2016; and Aczone Prescribing Information; February 2016.