Paratek announced that the Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Applications (NDAs) for oral and intravenous (IV) omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
Omadacycline is an investigational, once-daily, broad-spectrum aminomethylcycline antibiotic that is related to tetracyclines. The NDAs were based on Phase 3 data from 2 studies in ABSSSI against linezolid and 1 study in CABP against moxifloxacin (OPTIC). Omadacycline met all of the required FDA and European Medicines Agency (EMA) primary endpoints in each study. The drug was also regarded as safe and well-tolerated by study patients.
“With both oral and IV formulations, omadacycline has the potential to be the first once-daily oral and IV tetracycline antibiotic approved in nearly 20 years. Based upon its demonstrated clinical profile, omadacycline enables physicians to transition their patients from hospital to home faster, thereby reducing overall health care costs,” said Evan Loh, MD, President, COO and CMO of Paratek.
Omadacycline has also been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the treatment of CABP and ABSSSI. An Advisory Commtitee meeting will be held to review these applications. The FDA has set a target Prescription Drug User Fee Act (PDUFA) date for October 2018.
For more information call (617) 807-6600 or visit ParatekPharma.com.