Ottawa fast-tracks access to nasal spray version of overdose antidote

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Health Canada has fast-tracked access to a nasal spray that can reverse the symptoms of an opioid overdose in its latest effort to combat a nationwide public-health crisis.

Until now, naloxone had only been available in Canada as an intramuscular injection, typically in the upper thigh. Injecting it into a person experiencing an opioid overdose can revive that person within a few minutes.

The U.S. Food and Drug Administration approved intranasal naloxone – also known by its trade name, Narcan – in November, and it became commercially available in that country in February. Advocates say the nasal spray is an easier and less intimidating way to administer the drug and it eliminates the risk of handling a contaminated needle.

In May, United States-based Adapt Pharma approached Health Canada for an application with nasal naloxone. On Wednesday, Health Minister Jane Philpott announced she had signed an interim order allowing it to be imported from the United States and sold in Canada while the department conducts an expedited review for authorization in Canada.

"The number of opioid overdoses in Canada is nothing short of a public-health crisis," Dr. Philpott said in a statement. "First responders, police and family members need immediate access to formats of naloxone that are easy to use so that needless deaths can be prevented."

A Health Canada spokesperson said the department is now working with the Canada Border Services Agency to facilitate the drug's importation and it could be available within days.

In March, Health Canada made naloxone available without a prescription, recognizing a need to make the drug more readily accessible in the face of soaring numbers of opioid deaths; available then only in injectable form, it was classified as a Schedule II drug, which means it is kept behind the counter and pharmacists are required to provide training and information about its use.

The College of Pharmacists of British Columbia says it will now consult with stakeholders on the scheduling of the intranasal, easier-to-administer version.

The availability of nasal naloxone will affect first responders. Currently, Vancouver and Surrey firefighters carry injectable naloxone, but others, such as Vancouver police, have been hesitant to follow suit.

"There was a safety concern," Vancouver Police spokesman Constable Brian Montague said Wednesday. "We are not medical professionals and don't have a lot of training in this sort of thing. We didn't want our officers having to deal with injections."

The new version removes that hurdle.

"We've made it very clear that once it was available in nasal form, we would be interested in providing it to some of our front-line officers that would run into these situations," Constable Montague said.

In the United States, police in Delaware County, Penn., were among the first law-enforcement agencies to adopt intranasal naloxone, said Thom Duddy, executive director of communications for Adapt Pharma.

"They have 14 police departments with over 400 police officers," Mr. Duddy said. "They were using naloxone in a different version and converted to the nasal naloxone."

More than 100 first-responder agencies are now equipped with nasal naloxone in the United States, he said.

From January through May of this year, at least 308 people in British Columbia died of illicit drug overdoses – a 75-per-cent increase over the same period last year, when 176 people died.

Fentanyl, a powerful synthetic opioid that just years ago was largely restricted to hospitals and people living with chronic pain, is now found in more than half of such deaths. It is often cut into other drugs and ingested unknowingly.

It's not yet known what Narcan nasal spray will cost in Canada. When the FDA approved it in November, Adapt Pharma announced two prices for a carton containing two devices, each containing four milligrams of the drug: a public interest price – for agencies that serve the public interest, such as first responders – of $75 (U.S.) and a wholesale price of $125.