Oral-Only Dosing Regimen of Nuzyra Approved for CABP

An oral-only dosing regimen of Nuzyra^® (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) has been approved by the Food and Drug Administration (FDA).

Nuzyra is a tetracycline class antibacterial indicated for the treatment of adults with CABP and acute bacterial skin and skin structure infections. The product is available as 150mg tablets of omadacycline (equivalent to 196mg omadacycline tosylate) in 6- and 30-count blister packages as well as single-dose vials containing 100mg of omadacycline (equivalent to 131mg omadacycline tosylate). 

Previously, the initial loading dose for Nuzyra was administered only by intravenous (IV) infusion for adults with CABP followed by a maintenance dose administered as either IV infusion or oral tablets. The approval of the new oral-only dosing regimen for Nuzyra allows for the initial loading dose to be administered as 300mg orally twice on day 1 for adults with CABP followed by the maintenance dose thereafter.

“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,” said Adam Woodrow, President and Chief Commercial Officer of Paratek. “Treating in this way potentially reduces or eliminates hospitalizations and the associated risk and costs from a hospital stay.”

Fasting is required for at least 4 hours prior to taking Nuzyra tablets. After oral dosing, no food or drink (except water) should be consumed for 2 hours and no dairy products, antacids, or multivitamins for 4 hours.

References

1. Paratek Pharmaceuticals announces FDA approval of Nuzyra^® (omadacycline) oral only dosing regimen for the treatment of community-acquired bacterial pneumonia (CABP). [press release]. Boston, MA: Paratek Pharmaceuticals, Inc.; June 1, 2021. 
2. Nuzyra [package insert]. Boston, MA: Paratek Pharmaceuticals, Inc.; 2021.