Paratek Antibiotic Meets Non-Inferiority Bar In First Phase III

Paratek's omadacycline was non-inferior to Zyvox (linezolid) in a Phase III clinical trial testing the antibiotics in serious skin infections, but the company's drug will have a broader market that includes pneumonia and urinary tract infections – possibly with reduced competition – if future studies are positive.

Scientist

Paratek Pharmaceuticals Inc. has one set of Phase III data for its broad-spectrum antibiotic omadacycline in the treatment of serious skin infections, but it will be about two years before the company can seek US and EU approvals, because it is waiting on results from a second Phase III clinical trial.

Boston-based Paratek's omadacycline met the thresholds set by the FDA and the European Medicines Agency (EMA) to show non-inferiority to Pfizer Inc.'s now-generic, narrow-spectrum antibiotic Zyvox (linezolid) in the treatment of acute bacterial skin and skin structure infections (ABSSSI) in the OASIS trial

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