First Over-the-Counter Naloxone Nasal Spray

The U.S. Food and Drug Administration (FDA) has officially approved Narcan in the form of a 4 milligram (mg) naloxone hydrochloride nasal spray for sale as an over-the-counter (OTC) nonprescription product. This represents the first naloxone product approved for use without a prescription.

Meanwhile, the FDA has begun working with stakeholders to continue providing the nasal spray products during the transition time to switch Narcan from prescription to OTC status, which will likely take several months. Any other dosages of the product will continue to be available by prescription only.

Meanwhile, in Canada, the Toronto Transit Commission (TTC) has announced improved access to naloxone through provision of the nasal sprays at collector booths and hubs through its stations. According to a TTC news release, “In the event of an opioid overdose emergency, designated trained TTC employees may administer naloxone when safe to do so, to temporarily reverse the effects.” Once the company completes its training, it anticipates having about 730 staff members trained on opioid-overdose prevention, recognition, and response.


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