Omadacycline Approved for Community-Acquired Bacterial Pneumonia

FDA new drug approval
The FDA has approved Nuzyra for the treatment of adult patients with CABP and acute bacterial skin and skin structure infections.

The Food and Drug Administration (FDA) has approved Nuzyra (omadacycline; Paratek) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). It is the first once-daily antibiotic approved to treat CABP and ABSSSI that is available in both an intravenous (IV) and oral formulation.

Nuzyra, an aminomethylcycline (related to tetracycline antibiotics), is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains. Specifically, it is indicated for CABP caused by Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae and ABSSSI caused by S. aureus (methicillin-susceptible and -resistant isolates), S. lugdunensis, S. pyogenes, S. anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and K. pneumoniae.

The approval was based on Phase 3 data from 2 studies in ABSSSI, where treatment with Nuzyra was compared with linezolid, and 1 study in CABP comparing Nuzyra with moxifloxacin. Across all 3 trials, Nuzyra was found to be effective and generally safe and well-tolerated.

Each single-dose vial of Nuzyra contains 100mg of omadacycline which must be reconstituted and further diluted before IV infusion. Nuzyra tablets are supplied in a 150mg dosage strength. For patients with CABP, the loading dose should be administered by IV infusion; in ABSSSI patients, the loading dose can be given intravenously or orally.

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“Nuzyra offers clinicians the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation,” said Evan Loh, MD, President, Chief Operating Officer, and Chief Medical Officer, Paratek. “This potentially helps reduce hospitalizations and the costs associated with hospital stays.”

Nuzyra is expected to be available sometime in the first quarter of 2019.

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This article originally appeared on MPR