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LATEST
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Naloxone Nasal Spray Nears Over-The-Counter Sale After EMA Opinion

Uppsala: Naloxone nasal spray could soon be sold in the European Union without a prescription. At its meeting from 12 to 15 October 2026, the European Medicines Agency’s human medicines committee recommended changing the legal status of Nyxoid, a naloxone nasal spray, so that people can buy it without seeing a doctor first.

Nyxoid received its marketing authorisation from the European Commission in November 2017, and Mundipharma Corporation (Ireland) Limited holds it. The medicine is an emergency therapy for known or suspected opioid overdose with breathing problems or depression of the central nervous system. It is licensed for adults and adolescents aged 14 and over, and people without medical training can give it in non-medical settings as well as healthcare ones. Until now, the European Medicines Agency’s product page has said the medicine can only be obtained with a prescription.

The committee’s opinion matters because time decides the outcome of an overdose. Naloxone nasal spray blocks opioid receptors and can reverse slowed breathing within minutes, which gives bystanders a chance to act before an ambulance arrives. A prescription requirement puts a hurdle between naloxone nasal spray and the friends, relatives, hostel staff and outreach workers who are most likely to witness an overdose.

The scale of the problem explains the move. The European Union Drugs Agency estimated that at least 7,600 people died of overdoses in the Union in 2024, and it said that opioids were involved in about two-thirds of drug-induced deaths across Europe. Its report singled out an outbreak of fentanyl-related deaths in Bulgaria, with more than 100 cases in 2024 and 2025, and it noted that nitazene opioids drove deadly outbreaks in Estonia and Latvia. The agency also pointed out that Bulgaria lacks take-home naloxone programmes.

A scientific opinion does not change the shelves on its own. The European Commission normally follows the committee’s recommendation with a formal decision, and national authorities will then decide how the spray reaches the public, whether through pharmacies alone or through wider channels, and who pays for it. Some countries already hand out naloxone nasal spray through take-home programmes that give kits to people at risk, and those schemes will continue to matter for people who cannot afford to buy a product.

Public health groups will now push governments to clear the remaining barriers quickly. If the Commission confirms the change and capitals act, naloxone nasal spray could become as easy to find as other emergency medicines, and the European Union would give its citizens a simple, low-cost tool against a rising source of preventable death.