Sales of the overdose reversal medication naloxone increased after it was made available to the public without a prescription but then dipped quickly in the period following debut of over-the-counter sales, according to a new RAND study.
Over-the-counter sales of naloxone peaked during the first month of availability in September 2023, then declined rapidly before stabilizing until August 2024, when there was a small increase, according to the study published in the journal JAMA Internal Medicine. The drug can prevent death among people who have overdosed on fentanyl or other opioids.
While a sales dropoff might be expected for a medication meant to be kept on hand until an emergency, even the peak levels of over-the-counter naloxone sales were only 7.5% as large as the quantity of naloxone sold by prescription.
"While the FDA's approval of over-the-counter naloxone was intended to facilitate access to this life-saving medication, we found there was only limited uptake for over-the-counter sales," said Bradley D. Stein, the study's lead author and a senior physician policy researcher at RAND, a nonprofit research organization.
For the first time in many years, the number of Americans who died from opioid overdoses declined in 2023, attributed in part to the increased availability of naloxone.
Historically, Americans have obtained naloxone through prescription or free distribution programs. But in September 2023, naloxone became available over the counter with the hope it would increase access to the overdose reversal treatment.
Researchers analyzed sales information to calculate the county-level over-the-counter naloxone mean sales price and units sold per million county residents from September 2023 through the last week of September 2024.
They also reviewed pharmacy-dispensed naloxone rates from 2023, and program-distributed naloxone rates from August 2022 to August 2024.
There was considerable variation in the over-the-counter sales of naloxone across states, with Western states generally reporting higher sales. The national average was 396 over-the-counter units sold per million residents from September 2023 through September 2024. The average cost for a two-pack of naloxone nasal spray was nearly $45.
The amount of naloxone distributed by pharmacies or free programs was much larger than over-the-counter sales. State-level pharmacy-dispensed units per million residents averaged 7,063 in 2023, while program-distributed naloxone averaged 12,015 units per million residents from August 2022 through August 2024.
Biweekly over-the-counter sales of naloxone peaked at approximately 22.5 units per million from Sept. 16 to Oct. 21, 2023, then declined to about 15 units per million in early December 2023. Sales remained between 11 to 15 units per million through September 2024, except for a brief increase in August 2024.
"It's likely that the relatively high cost of over-the-counter naloxone has contributed to the limited sales," Stein said. "That cost is likely going to limit over-the-counter sales of this important medication in the fight against the nation's opioid crisis."
Researchers say that additional research should examine factors potentially influencing demand for over-the-counter naloxone, such as possibly requiring health insurance coverage for over-the-counter sales and promoting visible placement in retail outlets.
Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award number P50DA046351. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Other authors of the study are Rachel K. Landis, Rosanna Smart, Phoebe Levine, Abigail Kessler and Mark Sorbero, all of RAND, and Rosalie Liccardo Pacula of the University of Southern California.
RAND Health Care promotes healthier societies by improving health care systems in the United States and other countries.
