Naloxone, a substance capable of inhibiting the effects of opiates during an overdose, has just been authorized by the French Medicines Agency (ANSM). Addictology professionals are delighted, even if its implementation is still limited.
The French Federation of Addictology (FFA) has been asking for it for a long time, it’s done, the naloxone in the form of a nasal spray has been accepted in France. “It’s a very good idea. Useful, important and easy to use. All addictology players were impatiently awaiting this product ”, expressed himself Amine Benyamina, President of the FFA.
“This medication is intended for the emergency treatment of opioid overdoses while awaiting medical attention. It is already available from health professionals involved in the care of drug users ”, indicates the National Medicines Safety Agency (ANSM) in its decision. The naloxone is a substance that can very quickly reverse the effects of an opioid overdose (respiratory depression, loss of consciousness, coma).
In November 2014, the World Health Organization (WHO) recommended that the naloxone drug users and those around them to enable rapid management of an opioid overdose. The ANSM’s narcotics and psychotropic drugs committee issued a favorable opinion in this regard in 2015. The ANSM therefore granted a temporary authorization for use (ATU) for the nasal spray Nalscue®. The ATU enables rapid availability of a product that does not yet have a marketing authorization (AMM). Amine Benyamina, President of the FFA “Regrets that the introduction of the product is restricted” and hope “Rapid marketing authorization”.
Indeed, this antidote can only be prescribed by “Doctors working in an addictology support and prevention care center, in hospital addiction services, in emergency services, in any other service benefiting from an addiction care and liaison team and in sanitary units in hospitals ”.
Only pharmacies operating in health establishments will be able to dispense Nalscue®, which is a low number. Finally, lThe administration of this medicinal product absolutely requires complete training in what to do in the event of an overdose and in the use of the product administered.