The US Food and Drug Administration (FDA) has approved Sarecycline (Seysara, Almirall) for patients aged 9 years and older with inflammatory lesions associated with non-nodular moderate to severe acne vulgaris. Sarecycline is a new first-in-class tetracycline-derived oral antibiotic and the first one specifically designed for dermatologic use in 40 years, according to a company news release.
Sarecycline is a once-daily oral tablet with anti-inflammatory properties that can be taken with or without food. The approval follows consideration of data from two 12-week multicenter, randomized, double-blind, placebo-controlled studies that assessed efficacy in a total of 2002 patients aged 9 years and older that found the drug to be safe and effective. It significantly reduced inflammatory lesions as early as 3 weeks after beginning treatment.
The clinical trials have not established efficacy beyond 12 weeks nor safety beyond 12 months, and Sarecycline was not evaluated for the treatment of infections.
Sarecycline is contraindicated in those with hypersensitivity to any of the tetracyclines and may cause permanent tooth discoloration if used during tooth development. Tetracycline use has been associated with central nervous system side effects, including light-headedness, dizziness, and vertigo. The most frequently seen adverse effect (incidence ≥ 1%) is nausea.