On March 29, 2023, the U.S. Food and Drug Administration approved Narcan for over-the-counter sale. Narcan is the 4-milligram nasal spray version of naloxone, a medication that can quickly counteract an opioid overdose.

The FDA’s greenlighting of over-the-counter naloxone means that it will be available for purchase without a prescription at more than 60,000 pharmacies nationwide. That means that, for 90% of Americans, naloxone nasal spray will be accessible at a pharmacy within 5 miles from home. It will also likely be available at gas stations, supermarkets and convenience stores. The transition from prescription to over-the-counter status is expected to take a few months.

We are pharmacists and public health experts who seek to increase public acceptance of and access to naloxone.

We think that making naloxone available over the counter is an essential step in reducing deaths due to overdose and destigmatizing opioid use disorder. Over-the-counter access to naloxone will permit more people to carry and administer it to help others who are overdosing. Moreover, increasing naloxone’s over-the-counter availability will convey the message that risks associated with substance use disorder warrant a pervasive intervention much as with other illnesses.

Deaths from opioid overdoses across the U.S. have increased nearly threefold since 2015. Between October 2021 and October 2022, approximately 77,000 people died from opioid overdoses in the U.S. Since 2016, the synthetic opioid fentanyl has been responsible for most of the drug-involved overdose deaths in America.

Naloxone reverses overdose from prescription opioids like fentanyl, oxycodone and hydrocodone and recreational opioids like heroin. Naloxone works by competitively binding to the same receptors in the central nervous system that opioids bind to for euphoric effects. When naloxone is administered and reaches these receptors, it can block the euphoric effects of opioids and reverse respiratory depression when opioid overdose occurs.

There are two common ways to administer naloxone. One is through the prepackaged nasal sprays, such as Narcan and Kloxxado or generic versions of the drug. The other method is via auto-injectors, like ZIMHI, which deliver naloxone through injection, similar to the way epinephrine is delivered by an EpiPen as an emergency treatment for life-threatening allergic reactions.

The FDA will review a second over-the-counter application for naloxone auto-injectors at a later date. Although no interaction with a health care provider will be needed to purchase over-the-counter naloxone, when naloxone is purchased at a pharmacy, a knowledgeable pharmacist will be able to help people choose a product and explain instructions for use.

Research shows that when people who are likely to witness or respond to opioid overdoses have naloxone, they can save patients’ lives. This also includes bystanders as well as first responders like police officers and paramedics.

But until now, people in those situations could intervene only if they were carrying prescription naloxone or knew where to retrieve it quickly. Friends and family of people who use opioids are often given prescriptions for naloxone for emergency use. Over-the-counter naloxone will help make the drug more accessible to members of the general public.

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