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FDA approves Nuzyra oral-only dosing regimen for the treatment of community-acquired bacterial pneumonia (CABP).- Paratek Pharma

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Published:7th Jun 2021
Paratek Pharmaceuticals, Inc. announced that the FDA has approved the Company's supplemental New Drug Application (sNDA) for the oral-only dosing regimen of Nuzyra for the treatment of adults with CABP.

"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. Treating in this way potentially reduces or eliminates hospitalizations and the associated risk and costs from a hospital stay," said Adam Woodrow, President and Chief Commercial Officer of Paratek. "With the community expansion well under way we will broaden our promotional efforts to include this new dosing option and are particularly excited to bring primary care practitioners a new, safe and effective oral antibiotic in time for the upcoming pneumonia season." Approved by the FDA on 2 October 2018, Nuzyra is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of CABP and acute bacterial skin and skin structure infections (ABSSSI). The recently approved oral-only dose for CABP has an initial dose of 300 mg twice on day one 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 broad spectrum of bacteria, including Gram-positive, Gram-negative, and atypicals including other drug-resistant strains. "Treating serious community-acquired infections including pneumonia has become increasingly complex given significant bacterial resistance and major safety concerns seen with older generic antibiotics," said Christian Sandrock, M.D., M.P.H., FCCP, Professor of Pulmonary Medicine & Director of Critical Care, UC Davis Health. "Community-based physicians are in need of new effective and safe options given the lack of investment and innovation in the antibiotic ecosystem over the past two decades. The availability of an oral-only dosing regimen of Nuryra in pneumonia helps address a significant gap for an effective, safe and well-tolerated oral antibiotic in the primary care setting."

Condition: Infectious Diseases /CABP
Type: drug

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