Overdose : the Nalscue obtains an authorisation for the placing on the market

dimarik/epictura

Published the 31.07.2017 at 18h42

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overdoseopiacénaloxonedrogue

The course of the Nalscue has been somewhat difficult, but it ends with success. The antidote to overdose of opiates, in the form of a nasal spray, has just obtained authorization on the market (AMM) in France. The drug agency announced Friday on its website.

The drug, antagonist pure and specific morphine-like, allows a few seconds to reverse the effects of an overdose of opiates. It attaches to opioid receptors and displaces morphine from its receptor sites in order to stop its action.

Advances and limitations

Since 2015, the Nalscue was in receipt of a temporary authorization of use (ATU), which became effective a year later, and under very strict conditions – in a first time, at least. The patients of the cohort could benefit from it by making it in a CSAPA (centre for care, support and prevention in addiction) with a hospital pharmacy, which represents a fairly limited number of centres. In fact, access to this medicine that saves lives remained highly restricted.

In December 2017, the terms and conditions have been extended. From this date, the Nalscue can be provided in all of the CSAPA, as well as in the centres and structures with teams of mobile health care to people in situation of precariousness or exclusion managed by non-profit organizations. The access was easy, but brakes remained.

Here they are finally removed. The MSNA (national security agency of the drug) has issued the marketing authorisation, which will be effective in ” approximately three months “, the time to update the package leaflet and the labelling. By then, the conditions of access to the Nalscue remain the same as those of the ATU cohort.

Medical Prescription not required

In three months, therefore, the drug will be available on medical prescription, non-mandatory, the agency says. The CAARUD (Centres for the reception and accompaniment of risk reduction for drug users) may also be the issue.

The drug will be delivered to all persons at risk of overdose of opiates and their entourage, after provision of specific training to use (which is already the case currently), explains the agency.

Reduce the number of deaths

The administration of Nalscue is not a substitute for emergency care provided by a medical facility, reminiscent of the MSNA. Indeed, it is to act quickly to avert the lethal risk after a respiratory depression induced by overdose. Because very often, when help is visiting, or when the patient is inanimate is brought to the emergency room, it is already too late. So far, after administration of the spray, the call to the rescue (15 or 112) should be immediate and systematic.

In France, approximately 270 people have lost their lives as a result of an overdose of opiates (heroin…) or opioids (medication-based opiates) every year. An underestimate, as the Nalscue is intended to decrease the number.