RiVive, made by Harm Reduction Therapeutics, is the second over-the-counter naloxone product approved by the FDA this year.
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.
The company said it anticipates RiVive will be available in early 2024, primarily to harm-reduction organizations and state governments at a lower price than other opioid reversal nasal sprays.
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.
“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,” Michael Hufford, co-founder and chief executive officer of Harm Reduction Therapeutics, said in a statement.
Unlike other naloxone products, Harm Reduction Therapeutics said it will make RiVive available for free or at low break-even cost, which the company previously said was about $18.
Narcan is the most common naloxone product, and the 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 of around $50 can still be a barrier.
More options for opioid overdose reversal
