Mundipharma today welcomed the announcement by Federal Health Minister Greg Hunt MP that Nyxoid® (naloxone 1.8mg) nasal spray has been registered in Australia as an antidote to opioid overdose.1-4
At the moment, naloxone is only available in Australia for intramuscular or intravenous administration.
Nyxoid® has been registered by the Therapeutic Goods Administration as a Schedule 3 medicine and presents as a ready-to-use intra-nasal device that does not require preparation.1
This is important given the short window of opportunity for bystanders and first responders to act and prevent deaths and morbidities associated with opioid overdoses.2
The active substance in Nyxoid® works by rapidly displacing opioids from opioid receptors, counteracting their effect.1
“Mundipharma is fully committed to ensuring this medicine is in the hands of people at risk of overdose and people likely to witness an overdose,” said Jane Orr, Managing Director of Mundipharma Australia and New Zealand.
“We will continue to work closely with all stakeholders with a view to achieving an access model that maximises the opportunity to make this product available to those that need it.”
Mundipharma expects Nyxoid® stock to be available in early 2019.
Mundipharma has worked collaboratively with healthcare professionals to provide appropriate access to opioid pain relief over the past 20 years and is well positioned to introduce opioid overdose rescue medication. The company is committed to reducing opioid analgesic misuse and abuse and minimising its impact.
Please review the Product Information before prescribing. Approved Product Information can be accessed from 1800 188 009.
NYXOID® Nasal Spray
MINIMUM PRODUCT INFORMATION
NAME OF THE MEDICINE NYXOID naloxone hydrochloride dihydrate 2.2 mg/actuation nasal spray vial
Nyxoid is intended as part of the emergency treatment for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in:
♦the home or other non-medical setting
♦a health facility
For this reason, Nyxoid should be carried by persons at risk of, or likely to witness such events. Nyxoid is indicated in adults and children.
Hypersensitivity to any of the active substances or to the excipients.
Nyxoid is not a substitution for emergency medical care and cannot replace intravenous injection. Therefore, patients at risk or likely to witness an opioid overdose must be instructed in the proper use of Nyxoid.
A return of respiratory and/or central nervous system depression after an initial improvement in symptoms.
The effect of naloxone is based on the interaction with opioids and opioid agonists, reversing effects of opioids; rapid reversal may precipitate acute withdrawal syndrome in opioid dependence. At the usual naloxone dose there is no interaction with barbiturates and tranquillisers. In patients with multiple intoxication with opioids and sedatives or alcohol, the result of naloxone administration may be delayed, dependent on the cause of intoxication.
Very common: nausea; common: dizziness, headache, tachycardia, hypotension, hypertension, vomiting, post-operative pain Typical opioid withdrawal syndrome is expected with naloxone which may be caused by the abrupt withdrawal of opioid in persons physically dependent on them.
DOSAGE AND ADMINISTRATION
One spray of Nyxoid into a nostril. Re-administer Nyxoid, using a new Nyxoid container, into the other nostril after 2 to 3 minutes if the patient does not respond or responds and then relapses into respiratory depression. Further doses may be given every 2 to 3 minutes if needed until further assistance is available.
Please review Product Information before prescribing. Product Information is available from Mundipharma Pty Limited, 88 Phillip Street, Sydney, NSW 2000. Phone 1800 188 009.
DATE OF FIRST INCLUSION IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS (THE ARTG)
18 September 2018
® NYXOID is a trade mark of MUNDIPHARMA
- NYXOID Approved Production Information, September 2018
- Lewis CR, Vo HT, Fishman M. Intranasal naloxone and related strategies for opioid overdose intervention by nonmedical personnel: a review. Subst.Abuse Rehabil. 2017;8:79-95.
- Kerensky T, Walley AY. Opioid overdose prevention and naloxone rescue kits: what we know and what we don’t know. Addict.Sci.Clin Pract. 2017; 12:
- Jauncey ME, Nielsen S. Community use of naloxone for opioid overdose. Aust Prescr 2017;40:137-140.
- European Medicines Agency. Nyxoid Assessment Report.
- Walley AY, Xuan Z, Hackman HH, Quinn E, Doe-Simkins M, Sorensen-Alawad A, Ruiz S, Ozonoff A. Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: interrupted time series analysis. BMJ 2013; 346: