Once daily acne treatment approved by FDA

Allergan has announced that it has filed a New Drug Application NDA for Seysara (sarecycline) for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older with the FDA and the FDA has accepted the application. 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, multicenter, randomized, double-blind, placebo-controlled, Phase III 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. In March 2017, Allergan announced positive results of these Phase III studies, which met their primary efficacy endpoints.

Comment: Allergan completed the NDA submission in October 2017, and expects the Prescription Drug User Fee Act (PDUFA) action date to occur in the second half of 2018. Allergan has U.S. rights to the development and commercialization of Seysara. Paratek retains all ex-U.S. rights.