Admin_Adham
Jump to Key Points At its October 2026 meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended reclassifying Nyxoid (naloxone, Mundipharma Corporation Ltd) nasal spray as an over-the-counter medication.
The nonprescription recommendation aims to facilitate rapid, community-level intervention for confirmed or suspected acute opioid toxicity caused by substances such as heroin or morphine. Designed for administration by both healthcare personnel and non-medically trained bystanders, the needle-free formulation mitigates needle-stick injury risks and eliminates delays in emergency reversal while awaiting formal medical services.
Nyxoid is approved for adults and adolescents aged 14 years or older. It is a hybrid medicine containing the same active substance as the reference product, Naloxon HCl B. Braun, but is administered intranasally rather than by injection. The European Commission originally granted the drug marketing authorization, valid throughout the European Union, on November 10, 2017.
Rapid Reversal of Opioid Toxicity
Opioid toxicity can cause pinpoint pupils, severely slowed or irregular breathing, profound drowsiness, and unresponsiveness to touch or loud sounds. Naloxone rapidly blocks opioid receptors, counteracting the effects of opioids and reversing potentially life-threatening respiratory suppression.
- CHMP recommended Nyxoid naloxone nasal spray reclassification to OTC.
- Intended for suspected acute opioid toxicity; community-level, rapid reversal.
- Needle-free intranasal use may reduce needle-stick risk + EMS delays.
- Approved for adults + adolescents ≥14 years; 1.8 mg single-dose spray.
- Repeat dose in 2-3 min if no response; nausea + opioid withdrawal common.
Naloxone has been a cornerstone of emergency treatment for opioid toxicity since the 1970s. Evidence submitted by the manufacturer included published literature supporting its effectiveness when administered by injection — the standard approach — and through intranasal delivery.
In a study involving 38 healthy volunteers, intranasal administration of 2 mg naloxone by a healthcare professional produced blood concentrations of the drug similar to those achieved with a conventional 0.4-mg intramuscular injection.
Additionally, the company also conducted a real-world effectiveness study evaluating administration by untrained laypeople.
Dosing and Safety
Nyxoid is supplied in single-dose nasal spray containers delivering 1.8 mg of naloxone. When opioid toxicity is suspected, one spray should be administered into one nostril while emergency services are contacted.
If the initial dose has no effect, a second dose should be administered into the opposite nostril after 2-3 minutes. If the patient initially responds but subsequently deteriorates, another dose should be given immediately into the other nostril.
Nausea is the most common adverse effect, occurring in more than 1 in 10 people. People with opioid dependence may experience opioid withdrawal after administration, with symptoms including restlessness, agitation, nausea or vomiting, rapid heart rate, and sweating.
Detailed recommendations for use will be included in the summary of product characteristics published on the EMA website following the relevant European Commission decision on the product’s regulatory status.
