FDA Approves Second Over-the-Counter Naloxone Nasal Spray

FDA Approves Second Over-the-Counter Naloxone Nasal Spray

The product is an emergency treatment for opioid overdose.

  • By Robert Yaniz Jr.
  • Aug 02, 2023

The U.S. Food and Drug Administration (FDA) has just approved a second over-the-counter (OTC) naloxone nasal spray.

In a release dated July 28, the FDA announced it granted nonprescription approval of RiVive—a 3 milligram naloxone hydrochloride nasal spray—to Harm Reduction Therapeutics. The product is an emergency treatment for known or suspected opioid overdose, which accounted for more than 105,000 deaths in the 12-month period ending in February 2023 according to the FDA.

The FDA continues to support making naloxone products widely available to consumers. In March 2023, the FDA approved the OTC use of Narcan, another naloxone nasal spray. While details such as availability date and pricing are still undetermined, both products are heading to market. As a result, consumer access to naloxone is about to increase dramatically.

“We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health,” FDA Commissioner Robert M. Califf, M.D. said in a statement.

The National Safety Council found in 2021 that unintentional overdose deaths from nonmedical drugs or alcohol in the workplace increased 536 percent since 2011. The Centers for Disease Control and Preventionhas identified transportation and warehousing, construction and healthcare and social assistance as the industries with the most drug overdose deaths at work.

About the Author

Robert Yaniz Jr. is the Content Editor of Occupational Health & Safety.

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