FDA fast-tracks review of overdose-reversal drug for use without prescription

FDA fast-tracks review of overdose-reversal drug for use without prescription NEW YORK, NEW YORK - AUGUST 31: Shaun Willis, with the Brooklyn Community Recovery Center, demonstrates how to use Narcan to revive a person in the case of a drug overdose on August 31, 2022 in New York City. Nearly one million people have died of drug overdose deaths in America in the past two decades, with an increasing majority of those deaths due to synthetic opioids like fentanyl. The FDA has fast-tracked a review of another overdose-reversal drug made by Harm Reduction Therapeutics Inc. ( Photo by Spencer Platt/Getty Images/Getty Images)

By Debbie Lord, Cox Media Group National Content Desk

The Food and Drug Administration has granted a fast-track review of an overdose-reversal drug that would be available without a prescription.

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The drug, called RiVive, was developed by Harm Reduction Therapeutics Inc., a pharmaceutical nonprofit.

According to the company, its 3-milligram nasal spray delivered a three times higher concentration of naloxone, a drug that reverses the effects of a drug overdose, than if the medication was delivered in shot form.

According to the Wall Street Journal, the company said Monday that the FDA gave it a target approval date of April 28.

The FDA declined to comment, the Journal reported.

The company has promised to give away 10% of its product and sell at-cost the rest to pharmacies, public-sector employees and groups that work with drug addicts.

The cost would be around $18 a dose, according to HRT.

Emergent BioSolutions Inc., the maker of the Narcan brand of naloxone nasal spray, announced on Dec. 6 that it was expecting approval to sell its spray over the counter by March 29.

The two-dose prescription-only spray sells for around $100 (without insurance).