FDA Advisory Committee Recommends Approval of Paratek’s Omadacycline

Paratek Pharmaceuticals (NASDAQ:PRTK) today announced that the Antimicrobials Drug Advisory Committee of the U.S. Food and Drug Administration voted in favor of the approval of intravenous (IV) and oral omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) (17-1) and community-acquired bacterial pneumonia (CABP) (14-4).  Omadacycline is a modernized tetracycline being developed as a once-daily IV and oral, broad spectrum antibiotic for the treatment of serious community-acquired infections.

As quoted in the press release:

“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 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. “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.”

As part of its recommendation, the Advisory Committee considered data from the omadacycline global development program, which included three completed Phase 3 studies evaluating the safety and efficacy of the once-daily IV and oral formulations of omadacycline for the treatment of ABSSSI and CABP. In all three studies, omadacycline met all primary and secondary efficacy outcomes designated by the FDA and was generally safe and well-tolerated. A total of nearly 2,000 adult patients received omadacycline administered once-daily as part of the clinical trials. The Advisory Committee was asked to vote on whether the data provided substantial evidence of the safety and effectiveness of omadacycline in both ABSSSI and CABP.

Click here to read the full press release.