FDA Approves Narcan Nasal Spray to Treat Opioid Overdoses

With drug overdose deaths surging, the U.S. Food and Drug Administration (FDA) today approved Narcan naloxone nasal spray for over-the-counter nonprescription use. Naloxone rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose.

Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online. Other forms of naloxone are expected to be approved for OTC sale in the coming months.

While you might think that the epidemic of drug overdose deaths affects mostly younger people, it affects older people as well, according to a new study that finds drug deaths in the 65+ crowd has quadrupled over 20 years.

The deaths stemmed from both suicides and accidental overdoses, with nearly three-fourths of the unintended fatalities involving illicit drugs such as synthetic opioids like fentanyl, heroin, cocaine, and methamphetamines.

There were more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl.

“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status.

The FDA cautioned that it may take months for OTC versions of naloxone to become widely available but said it will work with manufacturers to move the process along.

Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug.  The application to approve Narcan nasal spray for OTC use was granted priority review status and was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription.

Older adult overdoses

In the study of overdoses among older adults, researchers found that fatal overdoses quadrupled from 1060 in 2002 (3 per 100,000 population) to 6,702 (12 per 100,000) in 2021.  The highest rates were among Blacks, at 30.9 per 100,000.

“The dramatic rise in overdose fatalities among adults over 65 years of age in the past two decades underscores how important it is for clinicians and policymakers to think of overdose as a problem across the lifespan,” said co-author Chelsea Shover, assistant professor of medicine in the division of general internal medicine and health services research at the David Geffen School of Medicine at UCLA.

“Updating Medicare to cover evidence-based treatment for substance use disorders is crucial, as is providing harm reduction supplies such as naloxone to older adults,” Shover said. The paper was published March 29 in JAMA Pychiatry.

The researchers used the U.S. Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research (WONDER) database to calculate annual overdose deaths among seniors from 2002 to 2021, comparing demographics, specific drugs, and whether the deaths were intentional, unintentional, or undetermined.