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Trial to test the safety and efficacy of acidified nitrite against P. aeruginosa respiratory infections in cystic fibrosis patients

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Trial Profile

Trial to test the safety and efficacy of acidified nitrite against P. aeruginosa respiratory infections in cystic fibrosis patients

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 06 Jun 2016

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At a glance

  • Drugs Nitrite (Primary)
  • Indications Cystic fibrosis-associated respiratory tract infections; Pseudomonal infections
  • Focus First in man; Therapeutic Use

    • Most Recent Events

    • 01 Jun 2016 According to an Arch Biopartners media release, the European Commission designated AB569 as an orphan medicinal product in the European Union for the treatment of patients with cystic fibrosis (CF). The orphan medicinal products designation is for the two active ingredients of AB569, sodium nitrite ethylenediaminetetraacetic acid (EDTA).
    • 26 Apr 2016 According to an Arch Biopartners media release, the European Medicines Authority (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion recommending AB569 for designation as an orphan medicinal product for the treatment of patients with cystic fibrosis (CF). The company plans to submit an IND application to the FDA in the second half of 2016.
    • 01 Mar 2016 According to an Arch Biopartners media release, the company submitted an orphan drug application for AB569 to the European Medicines Authority which is under review and the review period for the application is expected to end in late May, 2016.
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