• Federal government commits $7.2m for Take Home Naloxone pilot program5
  • NSW Coroner’s Court recommends immediate distribution to emergency services,
    those at risk of overdose, and those likely to witness overdose.6

Leading healthcare specialists, the federal government and the NSW Coroner’s Court have all welcomed the availability of the first ready-to-use intranasal naloxone spray, Nyxoid®, for the reversal of opioid overdose.1-4

Nyxoid® works by rapidly displacing opioids from opioid receptors, counteracting their effect.1 Naloxone has been used by paramedics and emergency clinicians in Australia for more than 40 years and has no abuse potential4

Mundipharma welcomed Therapeutic Goods Administration registration of Nyxoid® in September 2018 and pharmacies can now stock the medication for pharmacist-only over-the-counter sale.

Last month federal Health Minister Greg Hunt MP committed $7.2 million over two years to pilot a Take Home Naloxone (THN) program in Australia.5
Minister Hunt said: “a THN program will expand availability of naloxone to a range of additional settings frequently accessed by at-risk groups” in partnership with states and territories.

This month recommendations from the State Coroner’s Court of NSW called for the immediate distribution of naloxone nasal spray to NSW Ambulance officers, NSW police force members, GPs in areas with high opioid overdose prevalence, and Emergency Departments, “for the distribution to drug users suspected of having an overdose, and to their families and friends.6

The World Health Organisation also recommends that people likely to witness an opioid overdose, including opioid users, their friends and family, have access to naloxone and are trained in its use.7

The federal government has also provided more than $100,000 for research into the key principles and features of a nationally consistent THN model in Australia. The findings of this research will complement on the ground findings of the pilot and enable the THN model to be
refined to a national rollout.

Professor Nicholas Lintzeris from the University of Sydney, Division of Addiction Medicine said, “We know that naloxone saves lives, and the new intranasal delivery system provides a welcome alternative to existing formulations”.

“We need to ensure patients and their carers know how to prevent an overdose and what to do in the event of an overdose – including having ‘take-home’ naloxone in their possession.”

In Australia, rates of overdose mortality have increased steadily since 2000. The Australian Bureau of Statistics recorded 1,808 overdose deaths in 2016 – the highest in twenty years, with provisional data indicating a further increase in 2017.8,9

Jane Orr, Managing Director of Mundipharma Australia and New Zealand said the THN pilot program was a significant step toward ensuring Nyxoid® is readily available to any person at risk of overdose or likely to witness an overdose.

“It is wonderful that the Government has recognised the need for this medication and a national THN access program,” Ms Orr said. “The government’s commitment will be a great relief for clinicians and stakeholders who have highlighted the need to broaden the availability of naloxone and acknowledged that cost remains a barrier to universal access.

“It is encouraging to see that a number of states and territories are considering naloxone distribution by non-healthcare professionals suitably trained by healthcare professionals working in needle and syringe programs or outreach centres.”

In September 2018 Minister Hunt launched a Penington Institute report funded by Mundipharma, which recommends that:9

  • Naloxone be provided free-of-charge through key distribution points (e.g. needle and syringe programs, mental health services, pharmacies and hospital emergency departments);
  • People who inject drugs, people prescribed strong opioids, soon-to-be released prison inmates, and friends and family of people who use opioids have easy access to naloxone;
  • More professions, such as nurses and pharmacy staff, are authorised to supply naloxone to achieve national consistency.

“Our report found that intra-nasal naloxone has been included in several international naloxone distribution programs and should be prioritised within State-funded THN programs,” said John Ryan, CEO of Penington Institute. “Too often people suffering overdose die before emergency services are able to arrive, so we need people in the community to have the knowledge, training and equipment that could keep those people alive.”

Nyxoid® has been registered by the Therapeutic Goods Administration as a Schedule 3 medicine. Depending on individual pharmacy mark-up, a twin-pack of Nyxoid® intranasal spray will retail for between $75 and $85.

It is expected the Pharmaceutical Benefits Advisory Committee will review Mundipharma’s submission for a PBS listing of Nyxoid® in March 2019.

Mundipharma has worked collaboratively with healthcare professionals to provide appropriate access to opioid pain relief over the past 20 years. Through its work with leading clinicians and commitment to the Quality Use of Medicines, Mundipharma 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
INDICATIONS
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 setting.
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.
CONTRAINDICATIONS
Hypersensitivity to any of the active substances or to the excipients.
PRECAUTIONS
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.
INTERACTIONS
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.
ADVERSE EFFECTS
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
AU-4789
References
1. NYXOID Approved Production Information, September 2018.
2. 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.
3. 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: 4.
4. Jauncey ME, Nielsen S. Community use of naloxone for opioid overdose. Aust Prescr 2017;40:137-140.
5. Health Minister Greg Hunt MP Media Release. $268 million to continue the battle against alcohol and drug misuse. 2019. Available at http://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2019-hunt029.htm.
6. Inquest into the deaths of DB, RG, AH, JD, DC & AB. Decision of Deputy State Coroner Grahame on 1 March 2019. http://www.coroners.justice.nsw.gov.au/Documents/Opiate%20findings%20-%20final.pdf.
7. World Health Organisation. Community Management of Opioid Overdose Report. 2014. Available at https://www.who.int/substance_abuse/publications/management_opioid_overdose/en/
8. Australian Bureau of Statistics. 3303.0 – Causes of Death, Australia, 2016. Available at
http://www.abs.gov.au/ausstats/abs@.nsf/Lookup/by%20Subject/3303.0~2016~Media%20Release~Drug%20Induced%20Deaths%20Increase%20in%202016%20(Media%20Release)~9
9. Pennington Institute. Saving lives: Australian naloxone access model Report. 2018. Available at http://www.penington.org.au/wp-content/uploads/2018/10/Saving-Lives-Australian-naloxone-access-model.pdf