Porto: The naloxone nasal spray Nyxoid moved a step closer to over-the-counter sale across the Union after the European Medicines Agency’s human medicines committee recommended changing its legal status. The Committee for Medicinal Products for Human Use made the recommendation at its meeting from 12 to 15 October 2026, and the agency published its highlights on 16 October.
Nyxoid is a nasal spray that contains naloxone hydrochloride dihydrate in single-dose containers of 1.8 milligrams. The European Commission authorised it on 10 November 2017 as a hybrid of the injectable medicine Naloxon HCl B. Braun, and the marketing authorisation holder is Mundipharma Corporation (Ireland) Limited. Until now the naloxone nasal spray could be obtained only with a prescription.
The product serves as emergency therapy for known or suspected opioid overdose, with breathing or central nervous system depression, in non-medical and healthcare settings. It is approved for adults and adolescents aged 14 and over. The instructions are simple: one spray into one nostril as soon as an overdose is suspected, while waiting for emergency services. If there is no effect, a second dose goes into the other nostril after two to three minutes. The label stresses that it is not a substitute for emergency medical care.
The change in legal status for the naloxone nasal spray matters because speed decides outcomes in an opioid overdose. Bystanders, relatives and outreach workers are usually present before an ambulance arrives, and a medicine that anyone can buy without visiting a doctor puts the antidote closer to the people who need it. Public health agencies have long argued that wide availability of naloxone saves lives when paired with training and clear information.
The committee opinion does not take effect on its own. A CHMP recommendation goes to the European Commission, which adopts the formal decision that changes the product’s status in the Union register. Even then, national authorities decide how and where the naloxone nasal spray reaches shelves, pharmacies and community services, so access may differ between Member States for some time.
The recommendation came at a busy meeting. The committee recommended six new medicines for approval, bringing the 2026 total to 72, and backed five extensions of indication. It also confirmed its refusal of Yartemlea and declined to extend Mylotarg to children with newly diagnosed acute myeloid leukaemia. Against that crowded agenda, the naloxone decision shows the agency also acts on medicines that already exist and on how people reach them.
Harm reduction groups are likely to welcome a naloxone nasal spray that needs no prescription, while pharmacists and doctors will ask for clear guidance on supply, storage and patient information. Health ministries should use the coming months to prepare training for staff and information for people who use opioids and their families. If the Commission follows the committee, the naloxone nasal spray could become one of the most accessible emergency medicines in Europe.
