FDA OKs Treatment for Community-Acquired Bacterial Pneumonia and Skin Infections

FDA officials have approved omadacycline (Nuzyra, Paratek), a modernized tetracycline, to treat adults with acute skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

The drug is an oral antibiotic and once-daily intravenous that exhibits activity across a spectrum of bacteria, including atypicals, drug-resistant, Gram-negative, and Gram-positive strains.

The company plans on making Nuzyra available in the first quarter of 2019, according to Boston-based Paratek.

The FDA granted approvals for 100-mg injectable omadacycline and 150-mg tablets.

"In the face of ever-increasing antibiotic resistance, the FDA approved Nuzyra with a label having full approval for both CABP and ABSSSI. We are excited to bring to physicians an effective, well-tolerated monotherapy option for patients," Evan Loh, MD, Paratek's chief medical officer, chief operating officer, and president, said in a statement.

"Nuzyra offers clinicians the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation. This potentially helps reduce hospitalizations and the costs associated with hospital stays," Loh said.

Nuzyra is contraindicated in patients with known hypersensitivity to omadacycline- or tetracycline-class antibacterial drugs or to any of the excipients. In addition, mortality imbalance was observed in the CABP clinical trial with 8 deaths (2%) occurring in patients treated with Nuzyra compared with 4 deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age, and most of these patients had multiple comorbidities.