Paratek Pharmaceuticals, Inc. PRTK received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its lead drug NUZYRA (omadacycline) for the treatment of pulmonary Nontuberculous Mycobacterial (NTM) disease caused by both Mycobacterium avium complex (MAC) and Mycobacterium abscessus (MAB).
NUZYRA is being investigated in the phase 2b clinical study, currently enrolling subjects for the safety and efficacy in patients with NTM pulmonary disease caused by MAB.
Randy Brenner, chief development and regulatory officer, said, “Fast Track designation opens the door to more frequent dialogue with the FDA and the opportunity to expedite development of NUZYRA as an option to help patients with NTM pulmonary disease and health providers who struggle to manage these devastating lung infections because of significant antimicrobial resistance or considerable tolerability challenges associated with many of the treatments used for NTM.”
NUZYRA was granted orphan drug designation by the FDA for NTM disease caused by both MAC and MAB in August 2021.
FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
Paratek Pharmaceuticals’ shares are trading higher 22 percent at $2.31 during after hours session