While Health Canada conducts an expedited review of a new drug submission (NDS) for naloxone nasal spray, Minister of Health Jane Philpott has signed an Interim Order temporarily allowing naloxone nasal spray imported from the US to be sold in Canada. Currently, the only form of naloxone available in Canada is injectable.
Adapt Pharma submitted the NDS to Health Canada in May 2016. The FDA approved Adapt’s Narcan naloxone nasal spray in November 2015.
The Minister of Health commented, “The number of opioid overdoses in Canada is nothing short of a public health crisis. 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. Extraordinary measures are required to address this crisis, so I have asked my department to conduct an expedited review of nasal naloxone for sale in Canada, and to enact this temporary measure that allows access to a product from the US while our review is underway.”
A statement from Adapt Pharma said, “Adapt Pharma is working closely with Health Canada and the individual provincial health authorities to rapidly implement an appropriate process to deliver and distribute Narcan Nasal Spray. We will continue to work with Canada’s regulatory bodies to operationalize Canadian access to this potentially life-saving medication.”
Read the Health Canada press release.
Read the Adapt Pharma press release.
