FDA approves another over-the-counter spray for treating opioid overdose

Washington — The approval of a second over-the-counter naloxone nasal spray for emergency treatment of a known or suspected opioid overdose is a “game-changer” for its lifesaving potential, the National Safety Council says.

On July 28, the Food and Drug Administration approved RiVive – a 3 milligram naloxone hydrochloride nasal spray – for OTC, nonprescription use. The move follows the agency’s approval, in March, of Narcan – a 4 mg naloxone hydrochloride nasal spray.

The agency’s approval of both products is part of FDA’s ongoing emphasis on facilitating access to naloxone and stem the tide of opioid overdoses in the workplace and among the general public. Naloxone quickly reverses an overdose by blocking opioids’ effects on the body, restoring normal breathing in two to three minutes for a person whose breathing has slowed or stopped, according to the Centers for Disease Control and Prevention.

Overdose deaths of all types accounted for nearly 9% of all workplace injury deaths in 2021, according to NSC’s Injury Facts website.

“Access is everything,” Janice Hartgens, vice president of the council’s Naloxone in Every Workplace initiative, told Safety+Health. “Raising awareness for the public to be able to purchase naloxone over the counter is certainly a game-changer, as well as having access for employers to provide this in the workplace.”

Between 2019 and 2020, opioid-involved death rates in the United States rose 38%, according to CDC, with death rates involving a synthetic opioid jumping 56%. 

Hartgens said employers should implement a naloxone program and train workers.

“A lot of times, what employees learn at work, they take home,” she said. “They learn first aid at work, then they get a first aid kit for the home. This is an opportunity to train people at work on how to save a life at work and, hopefully, have them go to the pharmacy and buy their own naloxone and maybe one day save a life in the community.”

In a March 29 statement on FDA’s approval of the first naloxone nasal spray, NSC recommended employers take five steps to address the overdose issue:

• Assess readiness for having naloxone in the workplace.
• Ensure all legal and liability concerns are addressed.
• Establish workplace policies and procedures on responding to opioid overdoes with naloxone (pre-, during and post-overdose scenarios should be addressed).
• Get trained on how to respond to an opioid overdose with naloxone and necessary CPR after naloxone administration.
• Obtain naloxone.

“They agency has long prioritized access to naloxone products, and we welcome manufacturers of other naloxone products to discuss nonprescription development programs with the FDA,” agency Commissioner Robert M. Califf said in the release.