Last week, the U.S. Food and Drug Administration (FDA) approved a second over-the-counter naloxone nasal spray used to reverse opioid overdoses.
RiVive is a three-milligram treatment that will be available for little to no cost and joins the over-the-counter drug Narcan, which was approved by the FDA in March.
Unlike other FDA-approved opioid overdose products, RiVive’s manufacturer, Harm Reduction Therapeutics, will receive no profit from its sales.
Co-founder and Chief Executive Officer of Harm Reduction Therapeutics, Dr. Michael Hufford said, “We are grateful that the 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.”
According to the CDC, 75% of drug overdose deaths in 2020 involved an opioid. Opioid overdose deaths have increased by more than 700% since 1999. This phenomenon has been primarily linked to synthetic opioids cut with illegally manufactured fentanyl.
As a result of these increased deaths, the FDA is working to support harm reduction practices and advance overdose reversal drugs like naloxone, which is the standard treatment for quickly reversing the effects of an opioid overdose.
Harm Reduction Therapeutics says RiVive will be available by early 2024. The treatment will primarily be distributed to harm reduction organizations and state governments, but the company is seeking funding partners to make RiVive even more available.
Harm Reduction Therapeutics will first focus on offering the inexpensive treatment to communities with the most need. 10% of its projected year-one production—at least 200,000 doses—will be available for free.
Featured image from Harm Reduction Therapeutics.
