RiVive, made by Harm Reduction Therapeutics, is the second nonprescription naloxone product the FDA has approved. But unlike other opioid overdose products, the 3 milligram treatment will be available for free or low cost, and its sales will bring no profit to its manufacturer.
“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 Dr. Michael Hufford, co-founder and chief executive officer of Harm Reduction Therapeutics, Inc.
Naloxone products are the standard treatment for rapidly reversing effects of an opioid overdose — a persistent public health issue in the U.S.
In 2020, nearly 75% of drug overdose deaths involved an opioid, according to CDC data. These types of overdose deaths have increased by more than eight times since 1999, and in the past decade, increases have been significantly linked to synthetic opioids mixed with illicitly manufactured fentanyl.
In Spring, the FDA endorsed the main over-the-counter naloxone nasal shower, Narcan, and in May, it supported the first nalmefene hydrochloride nasal splash, Opvee.
Nalmefene is a narcotic receptor bad guy that has a more extended length of activity than naloxone at a similar portion, as indicated by the Public Establishments of Wellbeing. It requires a remedy, nonetheless, and is expected for use in medical care and local area settings.
The newly approved RiVive, according to Harm Reduction Therapeutics, will be available by early 2024, primarily to harm reduction organizations and state governments. But the nonprofit pharmaceutical company said it’s looking for additional funding partners to make RiVive even more accessible.
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