Allergan plc, has received approval from the U.S. Food and Drug Administration (FDA) to market ACZONE® (dapsone) Gel, 7.5%, a new prescription opical treatment for acne in patients 12 years of age and older. ACZONE® Gel, 7.5% delivers proven efficacy to treat both inflammatory and non-inflammatory acne, with a new concentration of dapsone in a once-a-day application.
In clinical trials of ACZONE® Gel, 7.5%, safety and efficacy were assessed in two identically designed, randomized, multicentered, double-blind, vehicle controlled 12-week studies. A total of 4,340 acne patients were randomized to receive either ACZONE® Gel, 7.5% (n=2162) or vehicle (n=2178). The majority of patients (99%; n=4339) had moderate acne, with a baseline score of 3 on the Global Acne Assessment Score (GAAS). ACZONE® Gel, 7.5% was approved based on co-primary endpoints of the GAAS and lesion counts (20 to 50 inflammatory and 30 to 100 non-inflammatory lesions at baseline).
At week 12, inflammatory lesions were reduced by 15.8 lesions (54.6%; n=2162) vs 13.9 lesions with vehicle (48.1%; n=2178), and non-inflammatory lesions were reduced by 20.7 lesions (45.1%) vs 18.0 lesions with vehicle (39.4%). The GAAS success rate in patients was 29.8% (n=2162) vs 21.1% with vehicle (n=2178).
In addition to efficacy, ACZONE® Gel, 7.5% has a proven tolerability profile. Out of 2161 patients who used ACZONE® Gel, 7.5%, 1.1% experienced mild application-site dryness vs 1.0% with vehicle (n=2175), and 0.9% of patients experienced pruritus vs 0.5% with vehicle.