Once-Daily Aczone Approved to Treat Acne
Allergan has received the FDA's permission to market dapsone gel, 7.5%, to patients aged 12 years and older with both inflammatory and non-inflammatory acne.
Allergan has received the FDA’s permission to market dapsone (Aczone) gel, 7.5%, to patients aged 12 years and older with both inflammatory and non-inflammatory acne.
The new concentration of gel provides patients with a once-a-day application option.
The FDA based its approval of Aczone’s new concentration on the safety and efficacy of 2 identically designed, randomized, double-blind 12-week studies involving more than 4000 acne patients. The trials demonstrated the efficacy and tolerability of Aczone.
"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, a lead investigator in the studies, in a press release. "This new formulation was well-tolerated, which is especially important to many of my female patients."
The most common adverse effect associated with Aczone is dryness at the application site.
Allergan will make Aczone available across the country beginning in May 2016.