FDA approves omadacycline oral regimen for community-acquired bacterial pneumonia

The FDA has approved omadacycline, an oral-only dosing regimen, for the treatment of community-acquired bacterial pneumonia, according to a press release from Paratek Pharmaceuticals.

Omadacycline (Nuzyra, Paratek Pharmaceuticals) is a novel antibiotic with once-daily oral and IV formulations for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. The once-daily oral-only dose has an initial dose of 300 mg twice on the first day followed by 300 mg once daily for 7 to 14 days, according to the release.

“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 Pharmaceuticals, said in the release. “Treating in this way potentially reduces or eliminates hospitalization and the associated risk and costs from a hospital stay.”

Omadacycline is a modernized tetracycline designed to overcome tetracycline resistance and exhibit activity across a broad spectrum of bacteria, including Gram-positive, Gram-negative and atypicals including other drug-resistant strains, according to the release.

“Treating serious community-acquired infections including pneumonia has become increasingly complex given significant bacterial resistance and major safety concerns seen with older generic antibiotics,” Christian Sandrock, MD, MPH, FCCP, professor of pulmonary medicine and director of critical care at UC Davis Health in Sacramento, California, said in the release. “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 2 decades.”

Nuzyra is contraindicated in patients with hypersensitivity to omadacycline or tetracycline class antibacterial drugs.