Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and for other public health threats for civilian, government and military use, today announced that the U.S. Food and Drug Administration (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 community-acquired bacterial pneumonia (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 October 2, 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.
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