Nyxoid

naloxone

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This is a summary of the European public assessment report (EPAR) for Nyxoid. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Nyxoid.

For practical information about using Nyxoid, patients should read the package leaflet or contact their doctor or pharmacist.

What is Nyxoid and what is it used for?

Nyxoid is a medicine used for emergency treatment in case of known or suspected overdose of opioid drugs (such as heroin or morphine).

Signs of overdose include pinpoint pupils, abnormally slow and irregular breathing, severe sleepiness and unresponsiveness to touch or loud noises. Nyxoid can be used in adults and adolescents from 14 years of age. It contains the active substance naloxone.

Nyxoid is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but is given in a different way. While the reference medicine Naloxon HCl B. Braun is given by injection, Nyxoid is given as a spray into the nose.

How is Nyxoid used?

Nyxoid is a nasal spray available in single-dose containers (1.8 mg). The recommended dose is one spray into one nostril given immediately on suspecting an opioid overdose and while awaiting emergency services; if the first dose does not have an effect, a second dose should be given after 2–3 minutes in the other nostril. If the first dose works well but the patient later worsens a second dose should be given immediately in the other nostril.

For further information, see the package leaflet.

The medicine can only be obtained with a prescription.

How does Nyxoid work?

The active substance in Nyxoid, naloxone, counteracts the effects of opioid drugs. Opioids work by attaching to and activating opioid receptors (targets) in the body. Naloxone rapidly blocks these receptors, ending the opioid’s effects such as slow breathing.

What benefits of Nyxoid have been shown in studies?

Naloxone, the active substance in Nyxoid, has been widely used in emergency medicine since the 1970s to treat opioid overdose. The company provided data from the published literature showing that naloxone is effective in treating opioid overdose when given by injection (the standard treatment for opioid overdose) as well as into the nose. In addition, a study involving 38 healthy volunteers showed that, when given by a healthcare professional, Nyxoid 2 mg given as a spray into the nose produced a similar level of naloxone in the body as naloxone given in the usual dose of 0.4 mg by injection into a muscle.

What are the risks associated with Nyxoid?

The most common side effect with Nyxoid (which may affect more than 1 in 10 people) is nausea (feeling sick). Typical opioid withdrawal syndrome is expected after Nyxoid is given to people addicted to opioids; symptoms include restlessness, agitation, feeling or being sick, a fast heart rate and sweating.

For the full list of all side effects and restrictions with Nyxoid, see the package leaflet.

Why is Nyxoid approved?

The safety and effectiveness of naloxone as an antidote for opioid overdose are well known. Compared with emergency treatments for opioid overdose given by injection, Nyxoid can be given by people with no medical training because it is sprayed into the nose. There is also no risk of needle injury with Nyxoid, and this could encourage members of the public to provide treatment promptly. Therefore, the European Medicines Agency decided that Nyxoid’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Nyxoid?

The company that markets Nyxoid will issue educational materials, including a video, for healthcare professionals and for patients with detailed information on how to use the medicine. The company will also conduct a study on the effectiveness of Nyxoid when given by people with no medical training.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nyxoid have also been included in the summary of product characteristics and the package leaflet.

Other information about Nyxoid

The European Commission granted a marketing authorisation valid throughout the European Union for Nyxoid on 10 November 2017.

For more information about treatment with Nyxoid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Nyxoid : EPAR - Summary for the public BG = bălgarski 2017-12-12  
Nyxoid : EPAR - Summary for the public ES = español 2017-12-12  
Nyxoid : EPAR - Summary for the public CS = čeština 2017-12-12  
Nyxoid : EPAR - Summary for the public DA = dansk 2017-12-12  
Nyxoid : EPAR - Summary for the public DE = Deutsch 2017-12-12  
Nyxoid : EPAR - Summary for the public EL = elliniká 2017-12-12  
Nyxoid : EPAR - Summary for the public EN = English 2017-12-12  
Nyxoid : EPAR - Summary for the public FR = français 2017-12-12  
Nyxoid : EPAR - Summary for the public IT = italiano 2017-12-12  
Nyxoid : EPAR - Summary for the public LV = latviešu valoda 2017-12-12  
Nyxoid : EPAR - Summary for the public LT = lietuvių kalba 2017-12-12  
Nyxoid : EPAR - Summary for the public HU = magyar 2017-12-12  
Nyxoid : EPAR - Summary for the public MT = Malti 2017-12-12  
Nyxoid : EPAR - Summary for the public NL = Nederlands 2017-12-12  
Nyxoid : EPAR - Summary for the public PL = polski 2017-12-12  
Nyxoid : EPAR - Summary for the public PT = português 2017-12-12  
Nyxoid : EPAR - Summary for the public RO = română 2017-12-12  
Nyxoid : EPAR - Summary for the public SK = slovenčina 2017-12-12  
Nyxoid : EPAR - Summary for the public SL = slovenščina 2017-12-12  
Nyxoid : EPAR - Summary for the public FI = suomi 2017-12-12  
Nyxoid : EPAR - Summary for the public SV = svenska 2017-12-12  
Nyxoid : EPAR - Summary for the public HR = Hrvatski 2017-12-12  

This EPAR was last updated on 12/12/2017 .

Authorisation details

Product details

Product details for Nyxoid
NameNyxoid
Agency product numberEMEA/H/C/004325
Active substance

naloxone hydrochloride dihydrate

International non-proprietary name (INN) or common name

naloxone

Therapeutic area Opioid-Related Disorders
Anatomical therapeutic chemical (ATC) code V03AB15

Publication details

Publication details for Nyxoid
Marketing-authorisation holder

Mundipharma Corporation Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union10/11/2017

Contact address:

Mundipharma Corporation Limited
Milton Road
Cambridge Science Park
Cambridge CB4 0AB
United Kingdom

Product information

Product information

10/11/2017  Nyxoid -EMEA/H/C/004325 --

Name Language First published Last updated
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17
Nyxoid : EPAR - Product Information HR = Hrvatski 2017-12-12 2018-01-17

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  
Nyxoid : EPAR - All Authorised presentations HR = Hrvatski 2017-12-12  

Pharmacotherapeutic group

All other therapeutic products

Therapeutic indication

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Nyxoid : EPAR - Public assessment report HR = Hrvatski 2017-12-12  
CHMP summary of positive opinion for Nyxoid HR = Hrvatski 2017-09-15  

Authorised

This medicine is approved for use in the European Union