Notice - Availability of Naloxone Hydrochloride Nasal Spray (NARCAN) in Canada

July 6, 2016

The Minister of Health has signed an Interim Order which authorizes the immediate importation and sale of NARCAN® Nasal spray for use in the emergency treatment of known or suspected opioid overdoses.

In order to be sold in Canada, NARCAN® Nasal spray will need to be accompanied by the U.S. labelling (PDF, 792 KB) as well as additional information required by the Minister of Health. This additional information includes instructions for use in French and instructions on how to report adverse drug reactions. This additional information will also be made available on the Health Canada website.

NARCAN® Nasal Spray will be available without a prescription.

Background

Drug overdose deaths as a result of opioid use and abuse are continuing to rise in Canada. Opioids are a class of drugs that include prescription medications such as oxycodone, fentanyl, hydrocodone, and morphine, as well as illegal drugs such as heroin. The continuing rise in drug overdose deaths in British Columbia led to the declaration of a public health emergency on April 14, 2016. In January alone, there were 74 overdose deaths in that province, and if the trend continues, the total number of deaths could far exceed the 474 deaths that occurred in 2015. Similar disturbing increases have been observed across Canada much of it as a result of the illicit use of prescription medications.

Naloxone hydrochloride is a life-saving medication that can stop or reverse the effects of an opioid overdose. It is currently available in Canada in a form that requires it to be administered by injection. Health Canada has recently taken steps to make naloxone hydrochloride available without a prescription in emergency situations outside of hospitals.

Naloxone hydrochloride is available in the United States (U.S.) in both an injectable form and as a nasal spray sold by the brand name NARCAN®(National Drug Code 69547-353-02). NARCAN® Nasal Spray is ready-to-use and does not require assembly, can be used on adults or children, and is easily administered by anyone, even those without medical training.

In approving the nasal spray, the U.S. Food and Drug Administration (FDA) noted that many first responders and primary caregivers felt that a nasal spray formulation of naloxone hydrochloride is easier to deliver, and eliminates the risk of a contaminated needle stick.

NARCAN® Nasal Spray is not currently available for sale in Canada. However, its manufacturer, Adapt Pharma Inc., has filed a New Drug Submission with Health Canada that could eventually allow for its sale in Canada. Until this occurs, the Minister of Health has determined that there is an immediate need for the product to be available in Canada to help address the ongoing health emergency that exists as a result of opioid overdoses.

For More Information

Contact

Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Address Locator: 3105A
Holland Cross, Tower B, 5th Floor
1600 Scott Street
Ottawa, Ontario
K1A 0K9
Email: LRM_MLR_consultations@hc-sc.gc.ca

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