FDA approves prescription topical Aczone for acne

Allergan announced in late February that the FDA approved its topical Aczone (dapsone) Gel, 7.5% for treatment of acne vulgaris.

The newly formulated Aczone 7.5% gel can be used once daily as opposed to twice-daily dosing on the older formulation, according to Metairie, La.-based dermatologist Patricia Farris, M.D.

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“… the once-daily dosing is a significant advantage, allowing Aczone to be used in the morning and a retinoid at night,” says Dr. Farris, who is a consultant for Allergan.

The prescription topical was approved for acne in patients 12 years and older.

Researchers studied 4,340 acne patients to demonstrate efficacy and tolerability in pivotal trials. In addition to once-daily dosing, Aczone offers a new pump delivery system, according to an Allergan press release.

In two randomized, multi-centered, double-blind, vehicle-controlled 12-week studies, patients received either Aczone Gel, 7.5% or vehicle. Ninety-nine percent of the study’s participants had moderate acne, with a baseline score of 3 on the Global Acne Assessment Score (GAAS), and 20 to 50 inflammatory and 30 to 100 noninflammatory lesions at baseline.

By week 12, inflammatory lesions in the active arm were reduced by 15.8 lesions, or54.6%, versus 13.9 lesions, or 48.1%, with vehicle. Among those receiving Aczone, noninflammatory lesions were reduced by 20.7 lesions, 45.1%, versus 18.0 lesions, or 39.4%, with vehicle.

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The GAAS success rate in patients was 29.8% in the Aczone group, compared to 21.1% with vehicle.

“This new formulation was well-tolerated, which is especially important to many of my female patients,” says Linda Stein Gold, M.D., director of dermatology clinical research, Division Head of Dermatology at Henry Ford Health System in Michigan and a lead investigator in the studies.

Aczone Gel, 7.5% will be available nationwide May 2016, according to the release.