US approves over-the-counter sale of lifesaving overdose treatment Narcan nasal spray

The lifesaving drug can instantly reverse the effects of an overdose

Opioid Crisis Naloxone Explainer (Copyright 2018 The Associated Press. All rights reserved.)

The US government has approved sales of the overdose-reversing nasal spray Narcan without the need for a prescription, a move that will dramatically expand access to the lifesaving drug.

The approval by the Food and Drug Administration (FDA) means that the spray will be available to buy online, in vending machines, supermarkets and convenience stores across the country, potentially by the end of the summer.

Naloxone, the generic name for the drug, rapidly reverses the effects of an opioid overdose by blocking the drug’s impact on the nervous system. Millions of doses have been administered by frontline health workers, but the nasal spray can be administered without medical training.

FDA Commissioner Dr Robert M Califf said the approval was aimed at addressing “the dire public health need” for ready access to the drug.

“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price,” Dr Califf said in a statement.

The opioid crisis began in the 1990s with the release of powerful new prescription drugs to treat chronic pain. Pharmaceutical companies promoted their new products with spurious claims that they were not as addictive as other opioids that came before. They became routinely overprescribed by doctors; it was not uncommon to see long lines outside pharmacies as people drove from miles away to pick up prescriptions.

Addiction soared and overdoses rose dramatically across the country. In 1994, the overdose death rate in the US was 4.8 deaths per 100,000 people. By 2015 it had more than tripled to 16.3 per 100,000. It has grown even higher since.

An estimated 107,622 people died from overdose deaths in 2021, an increase of nearly 15 per cent from the 93,655 in 2020, according to the Centers for Disease Control and Prevention (CDC). The synthetic drug fentanyl was to blame for most of the deaths.

Dr Patrizia Cavazzoni, director of the FDA’s Centre for Drug Evaluation and Research, described naloxone as “a critical tool in addressing opioid overdoses.”

“The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription status. Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to [over-the-counter] switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions,” she said in a statement.