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Paratek Pharmaceuticals (PRTK) Announces FDA Approval of NUZYRA Oral Only Dosing Regimen for Treatment of CABP

June 1, 2021 7:46 AM EDT

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 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.

“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 NUZYRA in pneumonia helps address a significant gap for an effective, safe and well-tolerated oral antibiotic in the primary care setting.”

About Paratek Pharmaceuticals, Inc.

Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

The Company’s lead commercial product, NUZYRA (omadacycline), is an oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

In 2019, Paratek was awarded a contract from BARDA, valued at ~$285 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax.

For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.



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