Posted by Michael Wonder on 21 Dec 2017
FDA accepts new drug application for Seysara (sarecycline) for the treatment of moderate to severe acne
20 December 2017 - Allergan and Paratek Pharmaceuticals today announced that the U.S. FDA has accepted a new drug application to review Seysara (sarecycline) for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older.
Seysara (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.
The application includes two identically-designed, large, multi-centre, randomised, double-blind, placebo-controlled, Phase 3 studies, which demonstrated that once-daily sarecycline 1.5 mg/kg significantly improved acne severity based on Investigator's Global Assessment success and significantly reduced inflammatory lesion count vs placebo at week 12 in patients with moderate to severe facial acne vulgaris.
