Allergan Announces FDA Approval of ACZONE
Allergan announced that the company has received approval from
the U.S. Food and Drug Administration (FDA) to market ACZONE®
(dapsone) Gel, 7.5%, a new prescription topical 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 just once-a-day
application.
In clinical trials of ACZONE® Gel, 7.5%, safety and efficacy were
assessed in two identically designed, randomized, multi-centered,
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% experienced pruritus vs 0.5% with vehicle.
“ACZONE® Gel, 7.5%, is a new once-daily option that was shown to
have significant improvement in patients’ acne after 12 weeks of
use,†said Linda Stein Gold, MD, Director of Dermatology Clinical
Research, Division Head of Dermatology at Henry Ford Health
System in Michigan and a lead investigator in the studies. “This
new formulation was well-tolerated, which is especially important
to many of my female patients.â€
