US approves overdose-reversing drug Narcan for over-the-counter purchase

Opioid overdose-reversing drug naloxone will soon be available for over-the-counter purchase in the United States, expected to arrive on shelves late this summer.

The Food and Drug Administration (FDA) approved the decision Wednesday, making naloxone the United States' first opioid treatment drug available to customers without a prescription. This comes as overdose deaths continue to skyrocket across the nation, averaging about 100,000 per year.

Today, the FDA announced that Narcan – an emergency medicine that reverses opioid-related overdoses – will now be available over the counter.

This action builds on our progress to reduce overdoses by expanding access to addiction care and reducing the supply of illicit drugs. https://t.co/NdGdUVnfgL

— President Biden (@POTUS) March 29, 2023

FDA officials are primarily concerned with the increasing presence of fentanyl– a powerful synthetic opioid– in less potent drugs like MDMA and cocaine.

"Because fentanyl is such a potent opioid, taking even a small amount can be deadly," said medical analyst Dr. Leana Wen in a March interview with CNN. "People may not be aware that they are taking the powerful drug. It’s very cheap to make, so some drug dealers are mixing fentanyl with other illicit substances, such as heroin, benzodiasepines, cocaine, MDMA and methamphetamines.”

Advocates believe it is important to get naloxone into the hands of those at risk, or close to those at risk, of overdosing.

"Putting it out on the shelves is going to allow people just to pick it up, not have stigma attached to it and readily access this life-saving drug,” said Jose Benitez, lead executive officer at Prevention Point Philadelphia, an organisation that works with those experiencing substance addictions.

The first form of nalaxone to reach customers will be Narcan– a medication known to reverse overdoses off of opioids, including street drugs such as heroin and fentanyl and prescription versions including oxycodone. It is made in a nasal spray by biopharmaceutical company Emergent BioSolutions, who anticipate that it will arrive to shelves in late summer.

Narcan will be available in pharmacies, convenience stores, supermarkets and online retailers.