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

The FDA has granted Orphan Drug Designation to Paratek Pharmaceuticals Inc's 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 the last check Thursday.