Abstract: Aims: With heroin overdose deaths rising in the UK, the MHRA (2013) supports making naloxone directly accessible to opiate users and their families. By enabling family members to administer the life-saving antidote while awaiting an ambulance, take-home naloxone could significantly reduce overdose death rates. However, the necessary regulatory change to over-the-counter status remains unlikely for as long as naloxone is only available as injectable formulation.
The aims of this project are to 1) develop a novel injection-free naloxone formulation and 2) establish an ethically feasible research strategy to test the product for its potential to reverse opioid action.
Methods: In partnership with the KCL Institute of Pharmaceutical Science, we have developed a buccal naloxone tablet using freeze-drying technology.
Prior to testing in a currently dependent population, we convened focus groups with current service users (n=7) and user representatives (n=2) to design a research strategy to test the new tablet for clinical effectiveness without exposing participants to severe withdrawal symptoms.
Results: A research strategy comprising a series of first-in-man clinical trials was jointly developed. For proof-of-concept in opioid users, an RCT was dismissed in favour of an open-label dose-escalation design. Users’ views on the buccal tablet were recorded and demonstrate cautious acceptability.
Conclusion: Through active involvement of service users with personal overdose experience, we have developed a research strategy that is sufficiently rigorous and reasonable from a user’s perspective. We are currently awaiting regulatory clearance to begin data collection on the first of three clinical trials.
Dr Jo Neale (King’s College London) Prof John Strang (King’s College London)