US FDA approves second over-the-counter opioid overdose reversal drug

The US Food and Drug Administration has approved the prescription-free sale of the second opioid overdose reversal drug, its manufacturer Harm Reduction Therapeutics said on Friday.

The approval of the drug, called RiVive, will provide patients with another over-the-counter option in the United States, where drug-related overdose deaths surpassed 100,000 in 2021.

Harm Reduction said it anticipates that RiVive will be available early next year, primarily to harm-reduction organizations and state governments. The not-for-profit drugmaker said it would make at least 200,000 doses available for free.

RiVive is a nasal spray version of naloxone, which rapidly reverses or blocks the effects of opioids, restoring normal respiration, especially when given within minutes of the first signs of an overdose.

"If we are able to have partners step forward and help fund our work, we can further lower the cost of RiVive, or increase the amount that we give away for free," the company's co-founder and CEO Michael Hufford said.

Emergent BioSolutions received the health regulator's nod in March for the first OTC version of Narcan, which is also a naloxone-based spray.

Harm Reduction Therapeutics has partnered with contract drug manufacturer Catalent Inc to manufacture RiVive.