FDA Approves Opioid-overdose Antidote Narcan for Over-the-Counter Use
On March 29, the U.S. Food and Drug Administration (FDA) approved the sale of Narcan, a brand name for the drug naloxone and the standard treatment for opioid overdose, without a prescription. The best-known form of naloxone is Narcan nasal spray, which can rapidly reverse the effects of an opioid overdose caused by prescription medications (e.g., oxycodone), heroin and fentanyl.
Opioids are linked to more than 100,000 deaths each year, according to the U.S. Centers for Disease Control and Prevention. The FDA’s approval of an over-the-counter (OTC) version of Narcan is a step toward making naloxone more widely available to help address the nation’s opioid crisis. Naloxone works by blocking the effects of opioids on the brain and restoring breathing. To be effective, a naloxone dose must be given as soon as signs (e.g., pinpoint pupils, unconsciousness and difficulty breathing) of an opioid overdose appear.
“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
- FDA Commissioner Dr. Robert Califf
Nearly all states already have standing orders that allow pharmacists to provide naloxone without a prescription to people at risk of an overdose or those helping someone at risk. The FDA’s latest approval builds upon that decision and expands the accessibility of the opioid antidote by offering an OTC version of Narcan.
What’s Next?
Opioid deaths are the leading cause of accidental death in the United States, affecting both adults and children. Advocates recommend that people who are most likely to be around overdoses, including people who use drugs and their relatives, should get naloxone. The OTC version of Narcan is expected to be available for purchase in stores and online by late summer.
Although the over-the-counter approval is a good first step to making overdose antidotes more accessible, the antidote’s cost and long-term impact are not yet known.
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