Paratek Submits NDAs for New Antibiotic

Paratek Pharmaceuticals, a biopharmaceutical company focused on tetracycline chemistry-based therapies, has completed the submission of two new drug applications (NDAs) to FDA for once-daily oral and intravenous (IV) formulations of omdacycline, its broad-specturm investigational antibiotic, the company announced on Feb. 5, 2018.

According to the company, omadacycline is the first in a new class of tetracycline antibiotics known as aminomethylcyclines. The company is seeking FDA approval for omadacycline for treating community-acquired bacterial pneumonia and acute bacterial skin and skin-structure infections. FDA has previously granted the antibiotic both qualified infectious disease product designation and fast track designation for these indications. These designations provide for a priority review of the NDAs, once accepted.

"The completion of our NDA submissions marks a significant milestone for Paratek and we are deeply grateful to the patients, investigators, and entire Paratek team for their commitment to advancing omadacycline's development path to this major milestone," said Evan Loh, MD, president, COO, and CMO of Paratek, in a company press release. "With antibiotic resistance on the rise, we look forward to working with [FDA] during the regulatory review process with the goal of bringing a modernized tetracycline antibiotic, omadacycline, to clinicians and patients for the treatment of serious community-acquired bacterial infections."