BY NATHANIEL WEIXEL | 07/28/23 1:01 PM ET
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.