Results from a Phase 3 clinical trial, OASIS-2, evaluating Paratek Pharmaceuticals’ (NASDAQ:PRTK) once-daily oral NUZYRA (omadacycline) in patients with acute bacterial skin and skin structure infections ((ABSSSI)) met all primary and secondary endpoints. The data were just published in The Lancet Infectious Diseases.
The study demonstrated omadacycline’s non-inferiority to twice-daily oral doses of linezolid.
On the safety front, the rates of nausea and vomiting for omadacycline were 30.2% and 16.8%, respectively, compared to 7.6% and 3.0%, respectively, for linezolid.
The FDA approved NUZYRA (both oral and IV formulations) in October 2018 for ABSSSI and community-acquired bacterial pneumonia (CABP). The company’s application in Europe is under EMA review.
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