Date: 2017-03-27
Type of
information: Completion of the trial
phase: 3
Announcement: completion of the trial
Company: Allergan (Ireland) Paratek Pharmaceuticals (USA - MA)
Product: sarecycline
Action
mechanism:
- antibiotic. Sarecycline is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties.
Disease: acne
Therapeutic
area: Dermatological diseases
Country:
Trial
details:
Latest
news:
- • On March 27, 2017, Allergan and Paratek Pharmaceuticals announced that two Phase 3 trials of sarecycline for the treatment of moderate to severe acne met their 12 week primary efficacy endpoints. Both SC1401 & SC1402 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 to placebo in the treatment of moderate to severe acne. The primary objective was 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%. Based on these data, Allergan plans to file a New Drug Application (NDA) to the FDA in the second half of this year.
Is
general: Yes
