Antidote to overdoses, Naloxone is now authorized in the form of a nasal spray in France. Access for users will be facilitated, but obstacles remain.
It was a long-awaited decision – for years, even. Naloxone, an opioid overdose drug, is now available as a nasal spray in France. The French Medicines Agency (ANSM) has just granted a temporary authorization for use (ATU) to this fast-acting antagonist, which makes it possible to stop the effects of an overdose (respiratory depression, miosis, analgesia) in one to two minutes.
Format usable by users
This is a real breakthrough, whereas until now, only the injectable form was available in France, delivered by emergency physicians. Professionals working in contact with users have led a fundamental fight to expand access to Naloxone, which has proven its effectiveness in reducing overdose-related mortality.
This expansion of access involved several things. First, there had to be a format that was easy for users to use, which is now the case. When prescribing the antidote, they will receive full training to learn how to use the nasal spray – the administration of which does not replace an emergency room visit, but saves time before help arrives.
The objective is also to familiarize consumers’ relatives with the administration of this spray, Nascue; data show that overdoses often take place in the presence of third parties.
Restricted issuance
To facilitate access to Naloxone, it was also necessary to allow a wider prescription and dispensing of the drug. However, from this point of view, progress remains timid in France. While nearly twenty American states allow dispensing without a prescription, in France, the conditions remain strict.
The drug may be prescribed to all people at risk of overdose, by “doctors working in Addiction Care, Support and Prevention Centers (CSAPA), in hospital addiction service, on duty emergencies, in any other service benefiting from the intervention of an addictology liaison and care team (ELSA) and in a prison health unit ”.
However, only CSAPAs with a hospital pharmacy will be able to dispense the drug, which is a small proportion. An astonishing decision, while the arbitrations seemed in favor of a wider distribution, as recommended by the World Health Organization. The Directorate General of Health (DGS) had issued a clear position on this subject, as had the ANSM’s Commission on Narcotic Drugs, in several opinions preceding the ATU.
Turnarounds
In the last moments of the arbitration, however, there seems to have been a turnaround on the side of the ANSM, which decided not to follow to the letter the advisory opinions issued by its own experts. Through its communication service, the Agency explains, however, that this is a “gradual provision” and that the other steps should follow, allowing the target to be broadened.
“By nature, an ATU concerns a limited number of prescribers; the laboratory is committed to requesting a marketing authorization, it is still indicated on the side of the agency. By having an MA, the Nascue should indeed be the subject of a less restricted issue.
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