FDA grants priority review for over-the-counter opioid overdose drug

Dec. 26 (UPI) -- The Food and Drug Administration has granted a non-profit pharmaceutical company priority review of its over-the-counter opioid overdose treatment as the United States combats an opioid epidemic.

Harm Reduction Therapeutics announced the approval of its RiVive 3 milligram naloxone nasal spray for priority review in a statement Monday, saying it expects a decision on its application to be made by April 28.

"When we formed Harm Reduction Therapeutics in 2017, we saw the urgent need to develop an OTC naloxone product, an action that no other company had pursued," Dr. Michael Hufford, co-founder and chief executive at Harm Reduction Therapeutics, said.

"Now, five years later and driven by our success in advancing RiVive toward FDA approval, the public health landscape is beginning to evolve, with OTC naloxone hopefully set to became a reality."

Naloxone, originally approved by the FDA in 1971, is a safe and effective opioid antagonist, which the U.S. Centers for Disease Control and Prevention suggests those at increased risk for opioid overdoes to have on their person. In most states, naloxone can be purchased at a local pharmacy without a prescription, it said.

The approval of RiVive by the FDA comes as it has been calling for naloxone to be made available over-the-counter as one way to fight deaths caused by opioid overdoses.

According to the CDC, there were an estimated 107,622 drug overdose deaths in the United States last year, representing a nearly 15% increase from a year prior. Overdose deaths involving opioids were nearly 81,000, which was an increase of some 10,000 deaths from 2020, it said.

In anticipation of FDA approval, Harm Reduction Therapeutics said it has entered into a commercial supply agreement with a manufacturer with expectations for the drug to be launched in early 2024.