Two pivotal phase 3 trials of sarecycline (Allergan/Paratek) for the treatment of moderate-to-severe acne have met their 12-week primary endpoints of efficacy and safety. Sarecycline is 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. Based on the data, Allergan plans to file a new drug application (NDA) with the FDA in the second half of this year.
The SC1401 and SC1402 trials were designed to be replicative phase 3, randomized, multicenter, double-blind, placebo-controlled studies to evaluate the efficacy and safety of 1.5 mg/kg per day of sarecycline compared with placebo in the treatment of moderate-to-severe acne.
The primary objective was to evaluate the efficacy and safety of oral sarecycline compared with placebo in treating inflammatory acne lesions in patients 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 per day) or placebo once a day for 12 weeks.
Sarecycline was statistically significantly (P < 0.004) superior to placebo with respect to the primary efficacy endpoints. The most common adverse events occuring in more than 2% of patients 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%.
Source: Allergan; March 27, 2017.