Paratek antibiotic delivers in post-marketing trial

July 19, 2024

Paratek Pharmaceuticals has announced positive results from a post-marketing study of Nuzyra (omadacycline), a broad-spectrum antibiotic, in treating moderate to severe community-acquired bacterial pneumonia (CABP).

The trial, which included 670 patients, showed that omadacycline met all primary and secondary efficacy endpoints, demonstrating non-inferiority to moxifloxacin. Moxifloxacin is a fluoroquinolone antibiotic used to treat various bacterial infections, including respiratory and skin infections, and bacterial conjunctivitis. 

The recent study for Nuzyra, OPTIC-2, reinforced omadacycline's efficacy and safety, mirroring results from the pivotal phase 3 OPTIC study. Paratek says that both studies contribute to the largest clinical dataset for pneumonia in any antibiotic approved by the FDA in the past decade. High clinical success rates were observed, and omadacycline was generally well-tolerated, with side effects similar to those reported in earlier studies.

Nuzyra stands out by being approved for both once-daily oral and intravenous use to treat community-acquired bacterial pneumonia and serious skin infections. Additionally, in 2019, Paratek secured a $304 million BARDA Project BioShield contract to develop Nuzyra against pulmonary anthrax.