FDA Approves Expansion of Community-Acquired Bacterial Pneumonia Therapy


Paratek’s omadacycline (Nuzyra) is granted approval for an oral-only dosing regimen in adults.

FDA approval

The Food and Drug Administration (FDA) approved an expansion for the therapy, Nuzyra, to include an oral-only dosing regimen for the treatment of Community-Acquired Bacterial Pneumonia (CABP) in adults.

Manufactured by biopharmaceutical company, Paratek, Nuzyra is a novel antibiotic with both once-daily oral and intravenous (IV) formulations. The oral-only dose for CABP has an initial dose of 300 mg twice on day 1 and 300 mg once daily thereafter for a total of 7 to 14 days. A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

“The approval of an oral-only dose regimen for Nuzyra in pneumonia represents a significant opportunity to offer clinicians the ability to treat patients in either the outpatient or primary care setting,” Adam Woodrow, president and chief commercial officer of Paratek, said. “Treating in this way potentially reduces or eliminates hospitalizations and the associated risk and costs from a hospital stay.”

Nuzyra had initially been approved by the FDA in October of 2018, and was indicated for the treatment of CABP and acute bacterial skin and skin structure infections (ABSSSI).

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