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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