Paratek Antibiotic Succeeds in Post-Marketing Trial

Paratek Pharmaceuticals has shared promising results from a post-marketing study of Nuzyra (omadacycline), a comprehensive antibiotic, for treating moderate to severe community-acquired bacterial pneumonia (CABP). This recent clinical trial, encompassing 670 patients, revealed that omadacycline met all principal and additional efficacy criteria, proving its effectiveness to be on par with moxifloxacin. Moxifloxacin is a well-established fluoroquinolone antibiotic commonly prescribed for various bacterial infections, including those affecting the respiratory system, skin, and eyes.

This study, labeled OPTIC-2, confirmed the effectiveness and safety of omadacycline, aligning with findings from the pivotal phase 3 OPTIC study. According to Paratek, these studies collectively form the most substantial clinical dataset for pneumonia compared to any other antibiotic approved by the FDA over the past ten years. The trials reported high success rates, and omadacycline was generally well-received by patients, with side effects comparable to those noted in previous research.

Nuzyra distinguishes itself by being approved for both once-daily oral and intravenous administration to combat community-acquired bacterial pneumonia and severe skin infections. Furthermore, in 2019, Paratek secured a $304 million BARDA Project BioShield contract to develop Nuzyra as a treatment for pulmonary anthrax.