The U.S. Food and Drug Administration has given the green light for the prescription-free sale of the second opioid overdose reversal drug, as announced by its manufacturer, Harm Reduction Therapeutics, on Friday.
The newly approved drug, named RiVive, will offer patients another over-the-counter option in the United States, where drug-related overdose deaths surged past 100,000 in 2021.
Harm Reduction Therapeutics expects to make RiVive available early next year, primarily to harm-reduction organizations and state governments. The not-for-profit drugmaker plans to distribute at least 200,000 doses for free.
RiVive is a nasal spray containing naloxone, a substance that swiftly reverses or blocks the effects of opioids, restoring normal respiration, especially when administered within minutes of detecting an overdose’s initial signs.
The company’s co-founder and CEO, Michael Hufford, expressed the hope for potential partners to contribute funding, allowing them to reduce the cost of RiVive further or increase the number of free doses they provide.
Prior to RiVive’s approval, the health regulator had already granted Emergent BioSolutions the green light in March for the first over-the-counter version of Narcan, another naloxone-based nasal spray.
Harm Reduction Therapeutics has collaborated with contract drug manufacturer Catalent Inc to handle the production of RiVive.
