CHMP recommends approval of Nyxoid (intranasal naloxone) for treatment of opioid overdose.- Mundipharma.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nyxoid (intranasal naloxone), from Mundipharma, intended for the treatment of opioid overdose. Nyxoid will be available as a nasal spray (1.8 mg).

Nyxoid is intended for immediate administration 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. Nyxoid is also indicated in adults and adolescents aged 14 years and over. Nyxoid is not a substitute for emergency medical care.

Comment: Opioid-induced death represents a significant public health problem responsible for 82 per cent of fatal drug overdoses in the EU, the majority of which are associated with heroin. Naloxone has been used in routine practice to reverse the effects of opioid overdose for more than 40 years, and is included in the World Health Organization (WHO) Model List of Essential Medicines.Mundipharma has developed an intranasal formulation to provide potential �first responders� in overdose situations with an easy to use, needle-free option that is suitable for use in a take-home naloxone setting. .