FDA grants expedited review for overdosed over-the-counter drug

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

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

Naloxone is a drug given to reverse the effects of a suspected opioid overdose. Under brands like Narcan, naloxone is generally available without a prescription, but sold behind the counter.

Co-founder and CEO of Harm Reduction Therapeutics, Michael Hufford, said advances in drug demand indicate “the public health landscape is beginning to shift” and that the low-cost over-the-counter drug is “hopefully -the about to become a reality”.

It will still be some time before the FDA appeals to RiVive, with an approval decision expected by the end of April 2023.

Anticipating a green light from the agency, the nonprofit says it has reached a commercial supply agreement and is preparing to launch the drug in the United States in 2024.

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

Researchers and drug makers are push to make the drug accessible without a prescription and without talking to a pharmacist behind the counter as the country faces a growing opioid epidemic.

Opioids are the leading contributor to drug overdose deaths in the United States, According to the CDC.

News of the latest push for expedited approval has been reported for the first time by the Wall Street Journal.