Relative Bioavailability of Nasally Administered Naloxone (QSC118264)
Research type
Research Study
Full title
A Randomised, Open Label Study Designed to Evaluate the Bioavailability of Nasally Administered Naloxone Formulations Relative to NARCAN® Nasal Spray in Healthy Subjects
IRAS ID
251017
Contact name
Martin Jönsson
Contact email
Sponsor organisation
Orexo AB
Eudract number
2018-002667-26
Duration of Study in the UK
0 years, 1 months, 7 days
Research summary
The Sponsor, Orexo AB, is developing a rapidly dissolving nasal powder formulation (recipe) of the medicine naloxone for administration into the nose for the treatment of opioid overdose. Opioids are a class of drug that include the illegal drug heroin, but also legal pain relieving medicines such as oxycodone, codeine and morphine. Opioid pain relievers are generally safe when taken for a short time and as prescribed by a doctor, but because they produce euphoria in addition to pain relief, they can be misused which can lead to overdose. \n\nNaloxone has traditionally been administered as an injection for opioid overdose. Recently liquid nasal sprays have been developed and marketed in Europe as well as in the US as needle free administration is beneficial. The Sponsor is developing a nasal powder formulation as a dry powder that will stick to the inside of the nose unlike a liquid formulation. This will reduce the potential for swallowing the medicine which in turn may reduce the variability in how much medicine is taken up by the body. \n\nThe study will involve up to 20 healthy male and female (non-pregnant, non-lactating) volunteers. Volunteers will receive 5 single doses of naloxone over 5 consecutive days in four new powder formulation and as the marketed nasal spray formulation (for comparison). Volunteers will remain in the clinical for a total of 6 days after dosing where blood samples will be taken and safety assessments will be performed for 24 hours after each dose. Inspections of the volunteer’s nose will be made throughout the study.
REC name
Wales REC 2
REC reference
18/WA/0306
Date of REC Opinion
13 Sep 2018
REC opinion
Favourable Opinion