Heroin overdoses tackled with naloxone nasal spray pilot in Norway
Researchers in Norway have developed a new naloxone nasal spray that could soon be given to drug users in the cities of Bergen and Oslo in a bid to reduce harm and deaths from heroin overdoses.
Development of the spray formulation of the opiate antidote has been led primarily by Ola Dale, a professor at the Norwegian University of Science and Technology in Trondheim, said Philipp Paul Lobmaier, a researcher at the Norwegian Centre for Addiction Research at the University of Oslo, who is leading the “bystander administration” part of the project.
He said he hopes that the spray will gain approval from the Norwegian Medicines Agency in the coming weeks and that it will be accepted by the drug user community. In the UK, there is no licensed nasal spray and questions have been raised by the UK Advisory Council on the Misuse of Drugs over the bioavailability and effectiveness of such a product. These concerns have not yet been addressed, warned Graham Parsons, a medicines optimisation pharmacist at the Northern, Eastern and Western Devon Clinical Commissioning Group and a former member of the ACMD.
However, Dr Lobmaier gave several reasons why his research team had chosen a nasal spray formulation. He said that worries about the bioavailability and effectiveness mainly stemmed from a 2008 study but that this study had used healthy volunteers with an intact swallowing mechanism and that swallowing limits the absorption of the spray. In contrast, he explained, people who have overdosed are unable to swallow and only take a few breaths every minute.
Dr Lobmaier said that the product his research team had helped develop had a smaller volume, a higher concentration and is in a “single-dose squeezy bottle”. In other countries the nasal spray consists of an atomiser attached to an injection syringe, which can be more difficult to administer, he said.
“It is easier to work with the nasal spray and it is safer to use. In Norway, at least 75 per cent of heroin-dependent people are hepatitis C positive and therefore the spray formulation presents less risk of transmission of either hepatitis C or HIV,” he said. He also suggested that there might be less stigma attached to carrying around a nasal spray compared with an injection.
Available free of charge to drug users
Dr Lobmaier told PJ Online that the plan is for the nasal spray to be made available for anyone who wants it free of charge, but that it is primarily aimed at drug users. It will be distributed through “low-threshold” centres, such as needle exchange programmes and shelters, which aim to make harm reduction services easily accessible.
Similarly, the UK is also planning on making naloxone more widely available; following a recommendation from the ACMD, the Medicines and Healthcare products Regulatory Agency recently ran a consultation that proposed amending the Human Medicines Regulations 2012 so that stocks of naloxone injections could be made available in settings such as hostels and for carers or family members of drug users. The outcome to the consultation is expected later this year.
Dr Lobmaier was positive about the possible idea of handing out naloxone nasal spray as part of opiate maintenance treatment delivered through pharmacies.
Mr Parsons said: “From a pharmacy perspective, and under the current legislation, pharmacy remains an ideal location for the distribution of naloxone under a patient group direction.” But he stressed that it was important that the service user is given training on the importance of contacting the emergency services following an overdose and in basic life support. “This, in my opinion, remains an important element of harm reduction and allows the service users to take their first steps on the road to recovery by engaging with services.”
But this advice appears to contrast with the study in Norway. The researchers will assess the outcomes of the project by looking at the number of ambulances called out to non-fatal overdoses before and after the introduction of the naloxone nasal spray.
Dr Lobmaier clarified that he hopes ambulances will still be called for overdoses, but that the paramedics will “find a person who is breathing rather than someone who is not breathing and has gone blue”. When an ambulance has been called, the research team will collect data on naloxone use and the patient’s level of consciousness, he said.
Dr Lobmaier told PJ Online that funding for the project is in place for two more years, after which the data will be submitted for publication.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11135511
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