US regulators have approved Paratek’s Seysara for the treatment of acne in patients aged nine years or older.
The once-daily pill is a narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting.
Approval was based on two 12-week placebo-controlled studies including 2,002 patients, in which Seysara (sarecycline) significantly reduced the severity of inflammatory lesions three weeks after treatment was started.
Seysara will be marketed in the US by Almirall, which picked up rights to the drug in the region from Allergan via the purchase of its US dermatology franchise, after the latter licensed US commercial and development rights from Paratek.
Paratek also announced US approval for Nuzyra (omadacycline), a treatment for adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections.
The firm said the drug has been authorised as once-daily intravenous (IV) and oral formulations, and that it intends to launch modernised tetracycline in the first quarter of 2019.