A 5 part, single site, open label, randomised, single dose, crossover study of Nyxoid (intranasal naloxone spray) in healthy volunteers.

Trial Profile

A 5 part, single site, open label, randomised, single dose, crossover study of Nyxoid (intranasal naloxone spray) in healthy volunteers.

Completed
Phase of Trial: Phase I

Latest Information Update: 03 Oct 2017

At a glance

  • Drugs Naloxone (Primary) ; Naloxone
  • Indications Opioid abuse
  • Focus Pharmacokinetics
  • Most Recent Events

    • 03 Oct 2017 New trial record
    • 15 Sep 2017 According to a Mundipharma International media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Nyxoid (intranasal naloxone 1.8 mg) for use in the emergency reversal of opioid overdose.The European Commission will now review the CHMP opinion and a final decision is expected in Q4 2017.
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