US clears over-the-counter spray for opioid overdoses

1 year ago 21
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Photo of a 4 mg Narcan nasal sprayImage source, Getty Images

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Naloxone, sold under the brand name Narcan, is known for being able to reverse an opioid overdose within minutes

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

The Food and Drug Administration's approval 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's commissioner Robert Cliff called the move "a dire public health need".

The move to widen the availability of Narcan is the latest effort to tackle an alarmingly high drug fatality rate in the country.

"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 Califf said in a statement on Wednesday.

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

Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug.

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.

Since its approval in 2015, Narcan has been available at pharmacies but only with a prescription. It has also been distributed through local health departments, community centres and needle exchange programs in some states.

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 an over-the-counter version of Narcan.

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