Paratek Pharmaceuticals Completes U.S. Manufacturing for Innovative Antibiotic NUZYRA®
Paratek Pharmaceuticals Completes U.S. Supply and Manufacturing for NUZYRA®
Paratek Pharmaceuticals, Inc. announced that it has finished establishing its U.S. supply and manufacturing capabilities for NUZYRA® (omadacycline) as of November 14, 2024. NUZYRA is a broad-spectrum antibiotic approved by the U.S. Food and Drug Administration (FDA) for treating community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
Evan Loh, M.D., the CEO of Paratek, emphasized that this development marks a significant milestone in their partnership with BARDA. This collaboration aims to enhance national security by creating a secure domestic supply chain, reducing reliance on foreign production.
Randy Brenner, Chief Development and Regulatory Officer at Paratek, highlighted the successful collaboration with BARDA, stating that they have met or exceeded many milestones. Paratek looks forward to completing studies to support a supplemental New Drug Application (sNDA) for NUZYRA, specifically for pulmonary anthrax treatment and prevention in the near future.
About Paratek Pharmaceuticals
Paratek Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative medical therapies that improve patient outcomes. Their lead product, NUZYRA® (omadacycline), is available in both oral and intravenous formulations for treating adults with CABP and ABSSSI. The company collaborates with Zai Lab Limited for the development of omadacycline in China, where NUZYRA received approval as an innovative drug in December 2021 for CABP and ABSSSI.
In December 2019, BARDA awarded Paratek a contract worth up to approximately $304 million, which supports the development of NUZYRA for pulmonary anthrax and security requirements for domestic manufacturing.
Paratek is currently conducting a Phase 2b study of NUZYRA for non-tuberculous mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex.
About NUZYRA®
NUZYRA® (omadacycline) is a next-generation tetracycline antibiotic with once-daily oral and intravenous formulations. It is approved for treating CABP and ABSSSI caused by susceptible bacteria. NUZYRA is effective against various strains, including Gram-positive and Gram-negative bacteria, as well as resistant strains.
Important Safety Information
- Contraindications: NUZYRA should not be used by individuals allergic to omadacycline or other tetracycline-class drugs.
- Warnings: There was a noted mortality imbalance in CABP trials, particularly in patients over 65 with comorbidities. Close monitoring of these patients is necessary.
- Adverse Reactions: Common side effects (≥2%) include nausea, vomiting, abdominal pain, and elevated liver enzymes.
- Drug Interactions: Anticoagulant therapy may need to be adjusted due to potential interactions with NUZYRA.
For more information, visit Paratek Pharmaceuticals or follow them on LinkedIn and Twitter.
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