The Food and Drug Administration on Friday approved the first version of over-the-counter (OTC) naloxone from a nonprofit company, a move that could bring cheap and even free doses of the opioid overdose drug to Americans who need it most.
RiVive, made by Harm Reduction Therapeutics, is the second over-the-counter naloxone product approved by FDA this year.
Naloxone is a medicine that can help reduce opioid overdose deaths and when administered quickly — usually within minutes of the first signs of an opioid overdose — can counter the overdose effects.
When administered soon after someone starts experiencing an overdose, the person will usually wake up within one to three minutes. Repeat administration of naloxone may be necessary.
Each RiVive device contains one dose of naloxone. It will be exclusively available in twin packs containing two single-dose devices of 3 milligrams each.
The company said it anticipates RiVive will be available in early 2024, primarily to harm-reduction organizations and state governments for costs lower than other opioid antagonist nasal sprays.
“We are grateful that FDA granted RiVive approval so we can now achieve what most thought impossible and no other company has: broad delivery of a lower-cost nasal naloxone product without a prescription to save lives that could otherwise be lost to opioid overdose,” said Michael Hufford, co-founder and chief executive officer of Harm Reduction Therapeutics, in a statement.
Unlike other naloxone products, Harm Reduction Therapeutics said it will make RiVive available for free or at low break-even cost.
The nonprofit said it is focused on supplying RiVive to communities that need it most and will make at least 200,000 doses (10 percent of projected initial annual product production) available for free.
“No company, entity, or individual will profit from sales of RiVive,” the manufacturer said.
Narcan is the most common naloxone product, and FDA approved an over-the-counter version in March.
But price can be a significant barrier because a two-pack of the prescription version can cost $130 to $150, depending on the retailer. Even the discount price can still be a barrier.
Public interest groups, such as government agencies, nonprofits and first responders, pay less than $50 on average for a kit of two 4-milligram doses, manufacturer Emergent said, and it is aiming for retailers to sell it at a similar price.
The FDA late last year began encouraging drug companies to apply to switch some forms of the drug away from prescription only, a move 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 Harm Reduction Therapeutics.
In a statement Friday, FDA Commissioner Robert Califf encouraged other companies to work with the agency on OTC naloxone.
“Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health,” Califf said. “The agency has long prioritized access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA.”
Updated at 1:09 p.m.