Nyxoid

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Questions & Answers

On 14 September 2017, 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, intended for the treatment of opioid overdose. The applicant for this medicinal product is Mundipharma Corporation Limited.

Nyxoid will be available as a nasal spray (1.8 mg). The active substance of Nyxoid is naloxone, an antidote that acts as opioid receptor antagonist (ATC code: V03AB15).

The benefits with Nyxoid are its ability to reverse symptoms of opioid overdose. The most common side effects are nausea and opioid withdrawal syndrome.

Nyxoid is a hybrid medicine1 of Naloxon HCl (solution for injection) which has been authorised in the EU since 2006. Nyxoid contains the same active substance as Naloxon HCl, but it is given into the nostrils.

The full indication is:

“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 indicated in adults and adolescents aged 14 years and over.

Nyxoid is not a substitute for emergency medical care.”

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


1 Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.

Name Language First published Last updated
CHMP summary of positive opinion for Nyxoid (English only) 2017-09-15  

Key facts

Product details for Nyxoid
NameNyxoid
INN or common namenaloxone
Therapeutic area Opioid-Related Disorders
Active substance

naloxone hydrochloride dihydrate

Date opinion adopted14/09/2017
Company name

Mundipharma Corporation Limited

StatusPositive
Application typeInitial authorisation