New long-term safety data for Almirall's Seysara

Spain’s leading drugmaker Almirall (ALM: MC) has announced the publication of long-term safety data from a 40-week, Phase III open-label extension study of Seysara (sarecycline) in patients nine years of age and older.

Seysara is a novel tetracycline-derived oral antibiotic developed specifically for the treatment of acne and was approved by the US Food and Drug Administration in October of 2018. Since it was launched in the USA in January of this year, Seysara has been prescribed for more than 60,000 patients, noted Almirall.

This long-term study included 483 subjects who had previously completed 12 weeks of Seysara treatment in one of two pivotal, randomized, double-blind, placebo-controlled, Phase III trials. The extension phase involved additional treatment of up to 40 weeks with Seysara.