U.S. FDA Approves Overdose-Reversing Drug Narcan to be Sold Without Prescription

In a major move, the leading manufacturer of naloxone, the overdose-reversing drug Narcan, has been approved by the U.S. Food and Drug Administration (FDA) for over-the-counter sales without a prescription. This decision will make Narcan the first opioid treatment drug in the U.S. to be sold without a prescription.

Naloxone against Opioid Overdoses

Narcan is a nasal spray form of naloxone, which can reverse opioid overdoses, including street drugs such as heroin and fentanyl and prescription versions including oxycodone. It works by blocking opioid receptors in the brain, reversing the effects of opioids like slowed breathing and confusion. Making naloxone more widely available is seen as a key strategy to control the nationwide overdose crisis, which has been linked to over 100,000 U.S. deaths annually.

Wider Availability

While naloxone is currently distributed to police and other first responders, advocates believe it is important to get it into the hands of people who are most likely to be around overdoses, including people who use drugs and their relatives. The approval of over-the-counter sales by the FDA follows its suggestion for changes on how the directions will be displayed on packaging and that naloxone can be safely used “without supervision” of healthcare workers.

Convenience in Distribution

The move clears the way for Narcan to be made available in places without pharmacies, such as convenience stores, supermarkets, gas stations and online retailers by late summer. Other brands of naloxone and injectable forms may also become available over-the-counter in the future.

Concerns Over Stigma

Pharmacies have been selling naloxone without prescriptions because officials in every state have allowed it, but not every pharmacy carries it and buyers have to pay for the medication, either with insurance co-pay or full retail price. Some people are concerned about getting naloxone at pharmacies because their insurers will know they’re getting it, and putting it out on the shelves is going to allow people just to pick it up without stigma attached.

Profitability Issues

There are fears that if the drug isn’t profitable as an over-the-counter option, the drugmaker could stop producing it. However, this hasn’t stopped Emergent BioSolutions Inc., the company who produces Narcan, from saying that they will step up availability of the drug at pharmacies and online retailers over the next few months.

Public Health Tool

Easy to use, Narcan has allowed everyday people to assist those experiencing an overdose and has been hailed by public health officials as a crucial form of assistance. According to the FDA on Twitter: “Anyone can save a life during an opioid overdose.”

The addiction crisis is primarily driven by the synthetic opioid fentanyl, which has eclipsed heroin and prescription painkillers as the main source of opioid addiction over the last five years. In 2021, more than 100,000 people in the U.S. died from drug overdoses, a 15 percent increase over the previous year.

Overall, wider availability of naloxone through over-the-counter sales is seen as a critical step in controlling overdose crisis in America. With accessibility improving and costs decreasing through over-the-counter sales, many hope that this will allow more people to conveniently access Narcan when they need it most while also destigmatizing addiction treatment.

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