According to the World Health Organization, around 69,000 people die from opioid overdose each year. Timely administration of the Rx drug, naloxone, can counteract the effects of overdose – although tragically, most overdoses occur far from a medical setting. Last week, Health Canada announced that it is working with local governments in provinces and territories to assess the rescue drug’s Rx-to-OTC switch, while Adapt Pharma Limited submitted a New Drug Application to the US FDA for Narcan (naloxone) Nasal Spray. An FDA workshop earlier this summer focused on expanding access to naloxone and the injectable delivery of the drug – was seen as a barrier to switch.
The overdose crisis and the generic availability of naloxone is creating the bottom-up model of switch. Traditional Rx-to-OTC switches are manufacturer-driven, with clinical and actual use studies conducted by drug owners and submitted to regulatory bodies. In the case of naloxone, expanded access is already being expedited at local government level in the US and Canada. In the beginning of 2015, California joined New Mexico, Washington, New York, Rhode Island, and Vermont in making naloxone available from pharmacists without a prescription. In many states / provinces and cities in the US and Canada, programmes equipping emergency first responders, including police officers, with naloxone, have been highly successful. Addiction clinics also provide opioid users with take-home naloxone kits and training for their families and friends in how to inject it in case of an opioid overdose. Data collected at local level should provide Health Canada and the FDA with compelling evidence in favour of an Rx-to-OTC switch of naloxone.