Paratek’s New Drug Applications for Oral and Intravenous Omadacycline Accepted for Priority Review by FDA

Paratek Pharmaceuticals (Nasdaq:PRTK) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Applications (NDAs) and granted a priority review for omadacycline, an investigational once-daily oral and intravenous (IV) broad spectrum antibiotic. Paratek is seeking approval of omadacycline, a modernized tetracycline, for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

As quoted in the press release:

“Antibiotic resistance is on the rise, and the need for new antibiotics is urgent. The FDA acceptance of these applications brings us one step closer to providing physicians an important new option in the fight against community-acquired infections,” said Evan Loh, MD, President, Chief Operating Officer and Chief Medical Officer of Paratek. “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.”

Click here to read the full press release.