Paratek announces FDA approval of omadacycline

FDA has approved omadacycline (Nuzyra—Paratek Pharmaceuticals) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). Omadacycline, which Paratek will make available in the first quarter of 2019, is a modernized tetracycline and a once-daily I.V.

FDA has approved omadacycline (Nuzyra—Paratek Pharmaceuticals) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). Omadacycline, which Paratek will make available in the first quarter of 2019, is a modernized tetracycline and a once-daily I.V. and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug-resistant strains. "We are excited to bring to physicians an effective, well-tolerated monotherapy option for patients," said Evan Loh, MD, president, chief operating officer, and chief medical officer, Paratek. "Nuzyra offers clinicians the ability to treat patients with the I.V. and transition them home to complete treatment with the oral formulation. This potentially helps reduce hospitalizations and the costs associated with hospital stays." Paratek's global development program completed multiple clinical trials and found the drug was well tolerated. The company has agreed to conduct post marketing studies in CABP and pediatrics as part of the approval.