Benzinga | Aug 19, 2021 06:36AM EDT

Paratek's Antibiotic Gets FDA Orphan Drug Tag For Lung Infection

* The FDA has granted Orphan Drug Designation to Paratek Pharmaceuticals Inc's (NASDAQ:PRTK), Nuzyra (omadacycline) for infections caused by Nontuberculous Mycobacteria (NTM).

* The orphan drug designation includes NTM pulmonary disease caused by Mycobacterium abscessus complex (MABc), currently in an ongoing Phase 2b study initiated by Paratek.

* Nuzyra is a once-daily, broad-spectrum antibiotic currently approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.

* Related: CDC Adds Nuzyra As Recommended Antibiotic For Plague Treatment.

* The Phase 2 trial is evaluating Nuzyra as a monotherapy in patients who are in the early treatment phase and are not receiving other antibiotic treatments.

* The study will enroll approximately 75 subjects, with the primary endpoint of improvement in symptoms and safety and tolerability following 12 weeks of treatment.

* Paratek expects the study will take about two years to complete enrollment.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: PRTK shares are up 0.77% at $ 5.25 during the premarket session on thelast check Thursday.