US approves first over-the-counter opioid overdose reversal drug Narcan

The US approved the first over-the-counter version of opioid overdose medication Narcan (Picture: AP)

Regulators in the United States have approved the first over-the-counter version of the anti-overdose medication Narcan.

Narcan, which is a 4 milligram dose of naloxone hydrochloride administered through a nasal spray, is one of the most popular drugs used to treat patients undergoing opioid overdoses.

On Wednesday, the Food and Drug Administration (FDA) greenlit the first version of the medication available without a prescription.

‘The FDA remains committed to addressing the evolving complexities of the overdose crisis,’ FDA Administrator Dr Robert M Califf said. ‘As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need.’

Narcan is designed to help individual overdosing on drugs such as fentanyl, heroin, or oxycodone (Picture: BRENDAN SMIALOWSKI/AFP via Getty Images)

The FDA is hoping the new version will increase the availability and affordability of the drug as the nation continues to struggle with the ongoing opioid epidemic. According to the FDA, there were over 101,750 fatal opioid overdoses in the last 12-month statistical period ending in October 2022.

The drug’s manufacturer, Emergent BioSolutions, plans to have the over-the-counter version available at pharmacies nationwide by late summer 2023.

Narcan works as an ‘opioid antagonist,’ according to the National Institute on Drug Abuse (NIDA). According to the government institute, it ‘attaches to opioid receptors and reverses and blocks the effects of other opioids.’

Emergent BioSolutions Inc hopes to have the over-the-counter version of Narcan available in pharmacies nationwide by late summer (Picture: REUTERS)

This process restores breathing in a person experiencing an overdose on opioids – including heroin, oxycodone, and morphine. If a person has no opioids in their system, Narcan has no effect on them.

The agency is hoping that Wednesday’s announcement will also encourage other drug manufacturers to market nonprescription naloxone products.

In 2021, the FDA approved the drug Kloxxado, a naloxone drug similar to Narcan but specifically designed to combat more powerful synthetic opioids like fentanyl.

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