FDA grants fast-track review for over-the-counter overdose drug

The Food and Drug Administration (FDA) is fast-tracking the review for a new opioid overdose reversal drug that would be available over the counter. 

The nonprofit pharmaceutical company Harm Reduction Therapeutics on Monday said in a release the FDA had granted it priority review for a new drug application for RiVive, a naloxone nasal spray for emergency overdose treatment.  

Naloxone is a drug administered to reverse the effects of a suspected opioid overdose. Under brand names like Narcan, naloxone is usually available without a prescription, but sold behind the counter.

Harm Reduction Therapeutics co-founder and CEO Michael Hufford said the drug application’s progress indicates “the public health landscape is beginning to evolve” and that the low-cost, over-the-counter drug is “hopefully set to become a reality.” 

It will still be a while, though, before the FDA makes a call on RiVive, with an approval decision expected by the end of April 2023.

Anticipating a green light from the agency, the nonprofit says it’s entered a commercial supply agreement and is preparing to launch the drug in the U.S. in 2024. 

The FDA earlier this month also granted priority review for Emergent BioSolutions Inc., the maker of Narcan, for a two-dose naloxone nasal spray, with an approval date expected in March 2023.

Researchers and drug manufacturers are pushing for the drug to be accessible without a prescription and without talking to a pharmacist behind the counter as the country deals with a growing opioid epidemic. 

Opioids are the leading driver of drug overdose deaths in the U.S., according to the CDC. 

News of the latest push for fast-track approval was first reported by The Wall Street Journal.