FDA News

FDA approves Nuzyra for treating adults with CABP, ABSSSIs

Evan Loh, MD
Evan Loh
Photo of Keith Kaye
Keith Kaye

The FDA has approved Nuzyra for treating adults with community-acquired bacterial pneumonia and acute skin and skin structure infections, according to Paratek Pharmaceuticals.

The company reported in a press release that Nuzyra (omadacycline), a modernized tetracycline, is the first and only once-daily IV and oral antibiotic to be approved for treating community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSIs) in nearly 20 years. It is active across gram-positive, gram-negative, atypical and drug-resistant strains of bacteria.

Nuzyra offers clinicians the ability to treat patients with the IV and transition them home to complete the treatment with oral formulation,” Evan Loh, MD, president, chief operating office and chief medical officer of Paratek, said in the release. “This potentially helps reduce hospitalizations and costs associated with hospital stays.”

The FDA approval was based on multiple clinical trials. Paratek Pharmaceuticals reported that nearly 2,000 adult patients received omadacycline; the study found the antibiotic to be efficacious, generally safe and well-tolerated. The company noted that mortality imbalance was observed in CABP clinical trials, with eight deaths (2%) occurring in patients treated with omadacycline compared with four deaths in patients treated with moxifloxacin. The cause of mortality was not established, and all patients were aged 65 years or older, according to the release.

Paratek reported it has agreed to conduct postmarketing studies in patients with CABP and pediatric patients.

“Treating pneumonia and skin infections has become increasingly complex as existing antibiotic therapies sometimes have reduced efficacy as resistance continues to grow. This reality makes it increasingly challenging to provide safe and effective treatments to patients,” Keith Kaye, MD, MPH, director of clinical research in the division of infectious disease at the University of Michigan, said in the release. “There continues to be a need for novel antibiotics with both IV and oral formulations, such as Nuzyra, to help physicians stay ahead of the evolving resistance landscape.”

Omadacycline is contraindicated in patients with hypersensitivity to omadacycline or tetracycline class antibacterial drugs, the company reported. The use of omadacycline also was related to possible permanent discoloration of teeth or enamel hypoplasia during tooth development, including the last half of pregnancy, infancy and in children aged 8 years or younger. Also, the drug may cause reversible inhibition of bone growth during the second and third trimester of pregnancy, infancy and in children aged 8 years or younger, according to the release.

Paratek Pharmaceuticals plans on making omadacycline available the first quarter of 2019.

Evan Loh, MD
Evan Loh
Photo of Keith Kaye
Keith Kaye

The FDA has approved Nuzyra for treating adults with community-acquired bacterial pneumonia and acute skin and skin structure infections, according to Paratek Pharmaceuticals.

The company reported in a press release that Nuzyra (omadacycline), a modernized tetracycline, is the first and only once-daily IV and oral antibiotic to be approved for treating community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSIs) in nearly 20 years. It is active across gram-positive, gram-negative, atypical and drug-resistant strains of bacteria.

Nuzyra offers clinicians the ability to treat patients with the IV and transition them home to complete the treatment with oral formulation,” Evan Loh, MD, president, chief operating office and chief medical officer of Paratek, said in the release. “This potentially helps reduce hospitalizations and costs associated with hospital stays.”

The FDA approval was based on multiple clinical trials. Paratek Pharmaceuticals reported that nearly 2,000 adult patients received omadacycline; the study found the antibiotic to be efficacious, generally safe and well-tolerated. The company noted that mortality imbalance was observed in CABP clinical trials, with eight deaths (2%) occurring in patients treated with omadacycline compared with four deaths in patients treated with moxifloxacin. The cause of mortality was not established, and all patients were aged 65 years or older, according to the release.

Paratek reported it has agreed to conduct postmarketing studies in patients with CABP and pediatric patients.

“Treating pneumonia and skin infections has become increasingly complex as existing antibiotic therapies sometimes have reduced efficacy as resistance continues to grow. This reality makes it increasingly challenging to provide safe and effective treatments to patients,” Keith Kaye, MD, MPH, director of clinical research in the division of infectious disease at the University of Michigan, said in the release. “There continues to be a need for novel antibiotics with both IV and oral formulations, such as Nuzyra, to help physicians stay ahead of the evolving resistance landscape.”

Omadacycline is contraindicated in patients with hypersensitivity to omadacycline or tetracycline class antibacterial drugs, the company reported. The use of omadacycline also was related to possible permanent discoloration of teeth or enamel hypoplasia during tooth development, including the last half of pregnancy, infancy and in children aged 8 years or younger. Also, the drug may cause reversible inhibition of bone growth during the second and third trimester of pregnancy, infancy and in children aged 8 years or younger, according to the release.

Paratek Pharmaceuticals plans on making omadacycline available the first quarter of 2019.