FDA approves Aczone Gel, 7.5% for treating acne

Issue: April 2016

Allergan plc announced that the FDA has approved Aczone Gel, 7.5% as once-daily topical treatment for patients aged 12 years and older with acne.

Aczone Gel, 7.5% (dapsone), a prescription medicine, was tested in two identical 12-week studies. It showed efficacy and tolerability in treating inflammatory and non-inflammatory treatment, according to a press release.

Linda Stein Gold

“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,” Linda Stein Gold, MD, study researcher and director of dermatology clinical research, and division head of dermatology at Henry Ford Health System in Michigan, stated in the release. “This new formulation was well-tolerated, which is especially important to many of my female patients.”

The FDA approval was based on results of the two 12-week double-blind studies in which a total of 4,340 patients with acne were randomized to receive treatment of the dapsone gel, 7.5% or vehicle. There were 99% of patients with moderate acne.

Inflammatory lesions were reduced by 15.8 lesions (54.6%) in the dapsone gel-treated cohort compared with 13.9 lesions (48.1%) in the vehicle-treated cohort. There was a reduction of 20.7 lesions (45.1%) in the dapsone-treatment arm compared with 18 lesions (39.4%) in the vehicle-treated cohort, according to the release.

There was a Global Acne Assessment Score success rate of 29.8% in patients treated with dapsone compared with 21.1% of vehicle-treated patients, the release reported.

There was proven tolerability profile for Aczone Gel, 7.5%, with 1.1% of 2,161 patients treated with the product experiencing mild application site dryness and 0.9% experiencing pruritis, compared with 1% and 0.5%, respectively, for 2,175 patients treated with vehicle, according to the release.

Allergan announced it expects Aczone Gel 7.5% to be available nationwide in May.

Reference: www.allergan.com