The Food and Drug Administration (FDA) has approved Seysara (sarecycline; Almirall, S.A.) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients ≥9 years old.
Seysara is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic. The approval was based on data from 2 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 results of the studies are encouraging, with statistically significant efficacy vs placebo as early as 3 weeks,” said Dr Leon Kircik, a dermatologist from Louisville, Kentucky and a sarecycline clinical trialist. The efficacy of Seysara beyond 12 weeks and safety beyond 12 months have not been established.
Seysara is expected to launch in January 2019. It is supplied as 60mg, 100mg, and 150mg tablets.
For more information visit Almirall.com.