Advisory Committee positive for omadacycline for ABSSSI and CABP.- Paratek Pharmaceuticals,

Paratek Pharmaceuticals, Inc.has announced that the Antimicrobials Drug Advisory Committee of the FDA 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 part of its recommendation, the Advisory Committee considered data from the omadacycline global development program, which included three completed Phase III 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.