FDA to consider omadacycline

FDA Considers Omadacycline

In October, the Food and Drug Administratin is expected to decide on the approval of omadacycline (Paratek Pharmaceuticals) for the treatment of acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia.

In August, the Paratek announced that the FDA’s Antimicrobials Drug Advisory Committee voted in favor of approving omadacycline, which is a tetracycline that has been developed in both intravenous and oral forms.

“Omadacycline has the potential to help address the urgent and growing need for new antibiotics to treat serious community-acquired infections. With once-daily dosing and bioequivalent intravenous 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. “Today’s recommendations from the Advisory Committee move us one step closer to making this important new treatment option available to patients and physicians. We look forward to working with the FDA as it considers the comments from the committee members and completes its review of the omadacycline new drug applications.”

The FDA based its decision on findings three phase three studies on acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia. In all three studies, omadacycline met all primary and secondary efficacy outcomes and was considered generally safe and well-tolerated.