Posted by Michael Wonder on 03 Oct 2018
Paratek announces FDA approval of Nuzyra (omadacycline)
2 October 2018 - First and only once-daily IV and oral antibiotic approved to treat both CABP and ABSSSI patients in nearly 20 Years.
Paratek Pharmaceuticals today announced that the U.S. FDA has approved Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). Nuzyra, a modernised tetracycline, is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug resistant strains. The Company plans on making Nuzyra available in the first quarter 2019.
The approval of Nuzyra is supported by multiple clinical trials within the company's global development program. Nearly 2,000 adult patients received Nuzyra and it was found to be efficacious and generally safe and well tolerated. As part of the approval, Paratek has agreed to conduct post marketing studies in CABP and paediatrics.
