Paratek announced that the Food and Drug Administration (FDA)’s Antimicrobials Drug Advisory Committee voted in favor of intravenous (IV) and oral omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
Omadacycline, an aminomethylcycline (related to tetracycline antibiotics), is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative, anaerobes, atypical bacteria, and other drug-resistant strains. The Committee’s recommendation was based on data from the omadacycline global development program that included nearly 2000 adults in three Phase 3 studies. Omadacycline met all primary and secondary efficacy outcomes in all 3 studies and was well-tolerated.
“With once-daily dosing and bioequivalent IV and oral formulations, omadacycline may help facilitate early discharge from the hospital or, in other cases, allow for safe and effective treatment in the outpatient setting,” said Michael F. Bigham, Chairman and CEO, Paratek.
The Prescription Drug User Fee Act (PDUFA) target date has been set for early October 2018. The FDA is not bound by the Committee’s recommendations but takes them into consideration for approval.
For more information visit ParatekPharma.com.