Paratek Sees Broad Potential For Omadacycline After Second Phase III Win

Paratek Pharmaceuticals will seek US FDA approval for omadacycline in early 2018 based on a second successful Phase III study for its antibiotic. The company believes the drug has broad potential against multiple pathogens and across multiple patient populations.

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Paratek Pharmaceuticals Inc. believes its antibiotic omadacycline, which it will submit for US FDA approval in the first quarter of 2018, has broad potential against a variety of pathogens and patient populations based on the drug's second successful Phase III clinical trial.

Boston-based Paratek reported on April 3 that its broad spectrum oral and intravenous antibiotic proved its non-inferiority to moxifloxacin in the treatment of community-acquired bacterial pneumonia (CABP), including the Phase III OPTIC trial's separate primary endpoints for FDA and European Medicines Agency (EMA) approvals

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