Sarecycline, a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting, met its 12-week primary efficacy endpoints.
Allergan plans to file a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) in the second half of 2017.
Both studies sought to evaluate the efficacy and safety of oral sarecycline 1.5 mg/kg per day compared to placebo in treating inflammatory acne lesions in subjects with moderate to severe acne based on Investigators Global Assessment (IGA) scale score and inflammatory lesion counts. Patients were randomized (1:1) into two treatment groups to receive either sarecycline tablets (60 mg, 100 mg and 150 mg, providing a dose of 1.5 mg/kg/day) or placebo once a day for 12 weeks.
Sarecycline was statistically significantly (p < 0.004) superior to placebo with respect to primary efficacy endpoints. The most common adverse events (>2%) reported in the sarecycline group were nausea (3.2%), nasopharyngitis (2.8%), and headache (2.8%). The rate of discontinuation due to adverse events among sarecycline-treated patients in the two studies combined was 1.4%.