FDA Approves Another Over-the-Counter Naloxone Product

The U.S. Food and Drug Administration (FDA) has approved a second over-the-counter naloxone product, The Hill reports. RiVive is the first version of OTC naloxone from a non-profit company, which says it will make at least 200,000 doses available for free.

The nonprofit, Harm Reduction Therapeutics, said RiVive should be available in early 2024. It will be distributed to harm-reduction organizations and state governments for free or at low break-even cost, which the company has said was about $18 each.

In the 12-month period ending in February 2023, more than 105,000 reported fatal overdoses occurred which were primarily driven by synthetic opioids like illicit fentanyl, according to a news release from the FDA.

“As we are seeing overdose death rates level off after years of rapid increases, we must do everything we can to double down on our efforts to end this epidemic. Today’s approval means that more life-saving overdose reversal products will be available over-the-counter for consumers, and more competition in the market should drive down costs,” White House Office of National Drug Control Policy Director Dr. Rahul Gupta said in a statement.