A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-Acquired Bacterial Pneumonia

Trial Profile

A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-Acquired Bacterial Pneumonia

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2018

At a glance

  • Drugs Omadacycline (Primary) ; Omadacycline (Primary) ; Moxifloxacin; Moxifloxacin
  • Indications Bacterial infections; Community-acquired pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms OPTIC
  • Sponsors Paratek Pharmaceuticals
  • Most Recent Events

    • 04 Apr 2018 According to a Paratek Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted two New Drug Applications (NDAs) and granted a priority review for omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). PDUFA Action Date is in October 2018. The FDA is currently planning to hold an advisory committee meeting to review these applications.
    • 05 Feb 2018 According to a Paratek Pharmaceuticals media release, Company has completed submission of two NDAs to the U.S. FDA for the indications of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP), the results of three successful Phase 3 pivotal studies.
    • 03 Jan 2018 According to a Paratek Pharmaceuticals media release, Company has initiated the rolling submission of an NDA to the U.S. FDA for the indications of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) and expects to submit the final components during the first quarter of 2018.
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