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.
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Posted In: BiotechNewsHealth CareFDAGeneralantibioticsBriefsOrphan Drug DesignationPhase 2
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