FDA Approves First OTC Naloxone Nasal Spray for Opioid Overdose Reversal
The approval comes as overdoses now account for over 100,000 deaths per year in the United States.
The U.S. Food and Drug Administration (FDA) approved the first over-the-counter (OTC) naloxone on Wednesday. The medication, a 4 milligram (mg) nasal spray, can be administered by anyone to reverse an opioid overdose.
The approval comes in the midst of an unrelenting opioid epidemic. The FDA announced in November 2021 that overdoses in the United States had reached 100,000 in a one-year period for the first time, largely fueled by fentanyl, an opioid that is more than 50 times more potent than heroin, according to County of Los Angeles Public Health.
Naloxone is sold in the United States under the brand names Narcan and Evzio, and this is the first naloxone product approved for use without a prescription.
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“Today’s approval of OTC 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,” FDA Commissioner Robert M. Califf, MD, said in a press release published Wednesday morning.
How Much Will OTC Narcan Cost?
In Wednesday’s statement, the FDA noted that the price will be determined by the drug manufacturer, Emergent BioSolutions. In its own statement, the manufacturer said the newly approved OTC Narcan should be available in the United States by late summer. The company has not yet said how much it will cost.
“Anyone will be able to access it without a prescription, which is an important step in the fight to reduce the number of opioid overdose deaths occurring each day,” the Emergent BioSolutions statement said.
Naloxone is available nationwide to people who have a prescription. However, the federal government has also already made it legal for pharmacies and healthcare facilities to carry and distribute naloxone to people who do not have a prescription, but how this is done is left up to the states.
There is no current federal standing order making naloxone available nationwide, but since 2014, all 50 states and Washington, DC, have implemented some kind of regulation that expands access to naloxone, and many have implemented state-level standing orders, according to The SAFE Project. This avenue often provides naloxone to those who need it for free or low-cost, but there are instances where some pharmacies have charged large amounts for the medication, says says José Martinez, a harm reduction associate at the National Harm Reduction Coalition and program associate at NEXT Distro, an organization that distributes free naloxone around the country.
How much the new OTC Narcan nasal spray will expand access to naloxone will hinge on the cost of the medication, he says.
“I think making this available over-the-counter will break down more barriers to access, but it really depends on the cost of it,” says Martinez. “That is the biggest thing we have to worry about. The point of it being over-the-counter is for access. We have to make sure it’s accessible for everybody.”
More Work Needed to Get Narcan Into Communities Most at Risk
Narcan nasal spray was launched for use by nonhealthcare professionals in 2016. While Narcan can be administered in different forms and doses, only the 4 mg nasal spray has been approved for over-the-counter sale.
Martinez says that as efforts to curb overdoses in the United States continue, the focus has to stay on making sure overdose-arresting medications are making it into the communities that are most affected.
“Overdoses are still out of control and that’s unacceptable. We need to understand how we can reach the community on the ground experiencing the overdoses, and I don’t think we’ve been diligent about that since the COVID-19 pandemic,” he says. “We have to do more to reach them.”