NYXOID (naloxone)

• Key points

Favourable opinion for reimbursement as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings.

• What therapeutic improvement?

A therapeutic improvement, like NALSCUE (naloxone), as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings.

• Role in the care pathway?

The management of opioid overdose is based on reversal of the effects of opioids via the emergency administration of naloxone, a pure and specific antagonist of morphine-like drugs with no agonist effects, along with ventilation of the patient.

At present, the naloxone-based medicinal products available in France are:

-    injectable naloxone-based medicinal products, for which a medical prescription is compulsory and which may only be dispensed in medical settings;

-    the proprietary medicinal product NALSCUE nasal spray solution (naloxone), for which medical prescription is optional, included in the hospital formulary list only, allowing it to be dispensed, in particular, in hospital structures, addiction care, support and prevention centres and drug user support centres, with no retail pharmacy availability in the absence of a price agreement. This proprietary medicinal product is indicated as emergency therapy for opioid overdose in adults and children aged one month and over;

-    the proprietary medicinal product PRENOXAD solution for injection in a pre-filled syringe (naloxone) for intramuscular administration, not subject to medical prescription, available in retail pharmacies and hospitals. This proprietary medicinal product is indicated as emergency therapy for opioid overdose in adults only.

Given the pharmacokinetic data available and the known efficacy and safety profile for naloxone, the Committee considers that NYXOID (naloxone) may be used in accordance with its MA, “as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings”.

Any person at risk of opioid overdose should benefit from a naloxone nasal spray kit.

• Special recommendations

The Committee recalls that the recommended NYXOID (naloxone) dose is 1.8 mg, corresponding to one single spray into one nostril (one nasal spray), unlike the proprietary medicinal product NALSCUE 0.9 mg (naloxone), which requires two sprays (one spray per nostril).