US clears over-the-counter spray for opioid overdoses

A drug that reverses opioid overdoses can now be purchased without a prescription in the US, officials said.

Approval by the Food and Drug Administration (FDA) means naloxone can be sold as a single-dose nasal spray in convenience and grocery stores.

Until now, Narcon – the nasal spray version of naloxone – was only available through a pharmacist or at local health centres.

FDA commissioner Robert Cliff called the move “a dire public health need”.

Widening the availability of Narcan is the latest effort to tackle an alarmingly high drug fatality rate in the US.

“Today’s approval of (over-the-counter) 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,” Mr Cliff said in a statement on Wednesday.

More than 100,000 Americans died from drug overdoses last year, according to the FDA. The vast majority were adults, though numbers show that teen overdose rates are rapidly rising.

Narcan has been available at pharmacies since it gained FDA approval in 2015, but only with a prescription. It has also been distributed through local health departments, community centres and needle exchange programmes in some states.

It reverses fatal overdoses by blocking the effect that opioids have on the nervous system. The nasal spray must be administered as soon as an overdose is suspected.

It can restore normal breathing to a person experiencing an opioid overdose in two to three minutes.

In cases involving more powerful opioids like fentanyl, more than one dose of naloxone is often required to reverse an overdose.

Wednesday’s action paves the way for the life-saving medication to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.

Currently, it applies only to a four milligram dosage of the drug. Other doses of naloxone will remain available through a prescription only, the FDA said.

The FDA and the pharmaceutical company behind Narcan, Emergent BioSolutions, said consumers will likely see the drug available over the counter in a few months.

Emergent BioSolutions has declined to disclose the price it plans for that version of Narcan.