FDA approves Nuzyra for CABP and ABSSSI.- Paratek Pharma.

Paratek Pharmaceuticals announced that the 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 modernized 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 pediatrics.

Comment: There are already a number of drugs on the market for these resistant infections, but most are narrowly focused and taken through an IV (intravenous), whereas omadacycline is being developed both as an IV treatment and a daily pill, which could give it an edge in administration.