Paratek Pharmaceuticals has announced the second positive Phase 3 registration study of omadacycline, which will be used to support marketing applications to the FDA and EMA planned for 2018. The Phase 3 clinical study compares Paratek’s broad spectrum investigational antibiotic, omadacycline, to moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia (CABP).
“This successful study demonstrates the potential of omadacycline to treat community-acquired bacterial pneumonia, a significant and serious health issue,” said Michael Bigham, Chairman and Chief Executive Officer at Paratek. “This Phase 3 study in pneumonia along with our previously announced successful Phase 3 study in skin infections satisfy the regulatory filing requirements of our special protocol assessment with the FDA. We look forward to sharing these data with the FDA and EMA. Our plan is to submit our NDA in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018.”
“Antibiotic resistance is a national issue as susceptibility rates have decreased across most antibiotics since 2010, underscoring the need for new, effective therapies. The positive top-line results of omadacycline in community-acquired bacterial pneumonia is welcome news,” said Dr. Thomas M. File Jr., M.D., MS, Chair of the Infectious Disease Section, Northeast Ohio Medical University, and Chair of the Infectious Disease Division, Summa Health. (Source: Paratek Pharmaceuticals Website, 03 April, 2017)
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