The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Seysara (sarecycline; Allergan and Paratek) for the treatment of moderate to severe acne vulgaris in patients ≥9 years of age.
Seysara is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic. The NDA includes data from two large, multicenter, randomized, double-blind, placebo-controlled Phase 3 trials involving patients with moderate to severe facial acne vulgaris. Results showed that compared to placebo, sarecycline 1.5mg/kg once daily significantly improved acne severity (based on Investigator’s Global Assessment success) and significantly reduced inflammatory lesion count at Week 12.
“The FDA’s NDA acceptance is encouraging as results shown in the Seysara Phase 3 trials involving 2,002 patients demonstrate that Seysara if approved, has the potential to be a new, effective, safe and well-tolerated treatment option for physicians treating patients with moderate to severe acne,” said Evan Loh, MD, President, Chief Operating Officer and Chief Medical Officer, Paratek.
The Prescription Drug User Fee Act (PDUFA) action date is expected to occur in the second half of 2018.