A 5 part, single site, open label, randomised, single dose, crossover study of Nyxoid (intranasal naloxone spray) in healthy volunteers.
Phase of Trial: Phase I
Latest Information Update: 03 Oct 2017
At a glance
- Drugs Naloxone (Primary) ; Naloxone
- Indications Opioid abuse
- Focus Pharmacokinetics
- 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.