The “lifesaving” and easy-to-use opioid reversal agent is now available for OTC purchase in pharmacies
Pharmacists and doctors have welcomed the availability of the first intranasal naloxone spray in Australia.
Ready-to-use intranasal spray Nyxoid contains 1.8mg naloxone (as 2.2mg naloxone hydrochloride dihydrate) in a concentrated 0.1mL solution.
It was first announced as having been registered as a Schedule 3 medicine with the TGA by Federal Health Minister Greg Hunt in September 2018.
Manufacturer Mundipharma now confirms that pharmacies can stock Nyxoid for over-the-counter sale, while the company is in discussion with a number of state and territory governments to make the take-home opioid reversal agent available at no cost to at-risk communities.
Jarrod McMaugh, pharmacist and board member of Harm Reduction Victoria welcomed the availability of Nyxoid.
“Anything that makes it easier for someone at risk of opioid overdose to access and benefit from a lifesaving opioid reversal agent is a big step forward,” he said.
“Not everyone in the community is comfortable handling syringes, so the availability of a discreet nasal spray that requires minimal training is an important development.”
The needle-free delivery system reduces the risk of needle-stick injuries for those who are administering the medicine.
Pharmacists should also consider recommending Nyxoid to people who are using opioid painkillers at high doses, Mr McMaugh tells AJP, as its nasal delivery system reduces some of the stigma associated with naloxone use.
“Most people who are using the naloxone are doing so because they might be using opioids recreationally and people who are doing that are probably not going to be worried [about using injections or spray] one way or the other,” he says.
“But there is a large amount of people who are getting a lot of opioid painkillers and they’re not realising that they’re at the same risk of overdose as everyone else. These people can be more comfortable with using nasal spray.
“I don’t think pharmacists necessarily think about providing naloxone for patients who are on high-dose opioids for pain, so there is a group of people who have a risk – not an overall high risk – but once people get above 50 mg eq morphine you should consider having access to naloxone at any time as it becomes more dangerous.”
Nyxoid would also be a good treatment option for people who are passed out, says Mr McMaugh.
“Unlike other nasal sprays, for example antihistamine sprays where you need to direct it in such a way that it hits the sinuses, with Nyxoid you can spray it into the nose and it will work regardless of directional placement of the device.
“You pretty much can’t get it wrong. There were some people who were worried that the dose would be too high but I don’t think it is. It’ll work and give people enough time to become conscious.
“There are many barriers to people at risk of opioid overdose having ready access to a reversal agent. Nyxoid has removed one of these barriers, but the focus now needs to be on ensuring easy and cost-effective access for those who will benefit from having one of these devices in their possession,” he added.
Depending on individual pharmacy mark-up, a twin-pack of Nyxoid intranasal spray will retail for between $75 and $85.
Meanwhile injectable naloxone (Prenoxad) without a prescription usually costs between $50 and $80.
With a prescription, this cost is reduced to a flat rate of $39.50, and for those with a health concession, further to $6.40.
Mundipharma said it has put in a submission for the Pharmaceutical Benefits Advisory Committee to consider PBS listing of Nyxoid, with a review due in March this year.
“We are hopeful of a favourable outcome,” said Jane Orr, Managing Director of Mundipharma Australia and New Zealand.
“In addition to seeking a PBS listing, Mundipharma continues to work with a range of stakeholders to achieve an access model that funds and facilitates distribution of take-home opioid reversal agents through recognised community touchpoints,” she said.
A recent report by the Penington Institute proposed a model for a national take-home naloxone program that makes the product available free-of-charge to those who need it – people at risk of overdose and people likely to witness overdose i.e. those using opioids, their friends and family members.
It suggested key distribution points would include pharmacies; needle and syringe programs (primary and secondary); select community agencies (that work with at-risk clients including outreach and homelessness services); custodial facilities (including remand and youth justice centres); drug treatment facilities and programs; and emergency departments.
“We believe that pharmacy is the key site that we can provide availability across the country,” said PSA national vice president Shane Jackson when the report was announced in September.
“The advantage of involving pharmacists, especially within community pharmacy, is that they may well be the only health professional that sees that individual who may be at risk.
“So they have an opportunity, once they’ve identified that a person may well be at risk of unintentional overdose, of being able to potentially supply that lifesaving naloxone to an individual, whether it be the injectable product or the future intranasal product,” said Dr Jackson.
“The intranasal preparation will hopefully reduce some of the stigma that might be associated with using an injectable product, so it might just improve accessibility and reduce some of the barriers to the availability of the product.”
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”.
“The intranasal formulation makes it much easier for members of the community to have and use naloxone in the event of witnessing a suspected overdose.
“The majority of overdoses in Australia occur with opioid medications prescribed by doctors, and many GPs, pain specialists and pharmacists have regular contact with people using opioid medication who may be at risk of opioid overdose,” said Professor Lintzeris.
“As health professionals, we need to identify risk factors for accidental opioid overdose in our patients. 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.”