Allergan announced that the Food and Drug Administration (FDA) has approved Aczone Gel 7.5%, a new topical treatment for acne vulgaris in patients aged ≥12 years.
Aczone, a sulfone, is already available as a 5% gel. Two identically designed, randomized, multi-centered, double-blind, vehicle-controlled 12-week studies assessed the safety and efficacy of Aczone Gel 7.5% in over 4,340 patients with acne. Study patients were randomized to receive either Aczone Gel 7.5% or vehicle.
At Week 12, inflammatory lesions were reduced by 15.8 lesions (54.6%) in the Aczone group vs. 13.9 lesions (48.1%) in the vehicle group. Non-inflammatory lesions were reduced by 20.7 lesions (45.1%) in the Aczone group vs. 18.0 lesions (39.4%) in the vehicle group. The Global Acne Assessment Score (GAAS) success rate in patients was 29.8% for those treated with Aczone vs. 21.1% for those treated with vehicle. Aczone Gel 7.5% also demonstrated a proven tolerability profile with 1.1% of patients experiencing mild application-site dryness and 0.9% experiencing pruritus.
Aczone Gel 7.5% is set to launch in May 2016.
For more information call (800) 433-8871 or visit Aczone.com.