FDA approves first over-the-counter drug for opioid overdose reversal

The first ever over-the-counter version of the opioid overdose reversal drug naloxone was approved by the Food and Drug Administration Wednesday, a move that could dramatically increase access to a life saving medication.

FDA approved Narcan, the brand name version of the drug manufactured by Emergent BioSolutions.

Naloxone is a medicine that can help reduce opioid overdose deaths and when administered timely, usually within minutes of the first signs of an opioid overdose, can counter the overdose effects.

There were nearly 107,000 reported fatal overdoses in 2021 primarily driven by synthetic opioids like illicit fentanyl. With naloxone, many of those deaths could have been avoided.

According to FDA, prescription Narcan is currently the most commonly sold emergency treatment for opioid overdose in United States pharmacies. It was first approved in 2015 to treat known or suspected opioid overdoses for people of all ages, including newborns. 

More than 44 million doses of Narcan have been distributed since its launch in 2016, the company said. 

Until now, it was only available with a prescription, though all 50 states have found workarounds to make the drug available at the pharmacy. Every state has “standing orders,” but not all pharmacies carry Narcan and the process can be complicated for pharmacists.

In addition, the people who need naloxone the most are also the least likely to go to a pharmacy and request it because of the stigma surrounding drug use.

The cost of the medication, requirements to show ID, and the overall stigma of asking for naloxone are all barriers. Additionally, some pharmacists may not be aware that there is a standing order in their state and refuse to prescribe the drug altogether.

According to the manufacturer, the 4 milligram over-the-counter version will be available by late summer. The prescription product will remain available through pharmacies and through community distribution.

“We are dedicated to improving public health and assisting those working hard to end the opioid crisis— so now with leaders across government, retail and advocacy groups, we must work together to continue increasing access and availability,” Emergent President and CEO Robert Kramer said in a statement. 

But the impact of making Narcan available over-the-counter will largely depend on how much it costs. Harm reduction advocates have expressed concern that it could be priced out of reach for groups that distribute it to people who need it the most.

A two-pack of prescription Narcan costs about $140, but with discounts the price is less than $50 a dose. The company has not said how much it will charge for the over-the-counter version.

“We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price,” FDA Commissioner Robert Califf said in a statement.

The FDA late last year began encouraging drug companies to apply to switch some forms of the drug away from prescription only, a move that advocates have long been pressing for as a way to increase access to naloxone.

But there are only two companies that applied for and were granted fast-track priority review to sell naloxone over the counter; Emergent, and the nonprofit company Harm Reduction Therapeutics.

FDA’s move to approve Narcan makes it likely the agency will also approve an over-the-counter version of Harm Reduction Therapeutics’ spray called RiVive. The company said it wants to sell its naloxone to harm-reduction groups at cost, which is $18 per unit.

Updated at 9:39 a.m.