Advisers to the Food and Drug Administration want Narcan to be made available for over-the-counter use.
A joint FDA advisory panel unanimously voted 19-0 to recommend the agency approve the anti-opioid overdose drug to be sold beyond pharmacies.
While Narcan is already available without a prescription in all 50 states, not all pharmacies carry it and those that do must keep it behind the counter, the Associated Press reported. The stigma of opioids also discourages people from asking the pharmacist for the drug.
FDA approval would allow more people to acquire the treatment more easily in more places.
Narcan, also known by its generic name naloxone, is a nasal spray that can quickly reverse the effects of an overdose from opioids such as heroin, fentanyl and prescription painkillers, helping to reduce opioid overdose deaths. The medicine is approved for use in all ages, including children who may accidentally ingest harmful drugs. It has no effect if given to someone not experiencing an opioid overdose.
A decision to make the antidote available over-the-counter would be "precedent-setting," the agency said, according to CNN.
"This is a very important step from the cultural perspective. A key component of our addressing the ongoing opioid crisis will be broadening community access to this medication and decreasing the stigma associated with the purchase of naloxone. We know from long experience that this is a safe and effective medication," Committee member Dr. Brian Bateman said, per CNN.
The the FDA has taken a number of steps to improve access to naloxone products over the last several years. In November, it issued a preliminary assessment that Narcan had the potential to be safe and effective for over-the-counter use and expressed optimism for switching certain naloxone products from prescription status to nonprescription status.
The switch would allow the drug to be sold beyond the pharmacy counter in vending machines, convenience stores and supermarkets, the AP said.
The FDA is expected to make a final decision on Narcan's status by the end of March.
There has been a sharp spike in opioid deaths in recent years, fueled in part by fentanyl, a powerful synthetic opioid that is intended for post-surgical use but is now found in a variety of street drugs. Provisional data from the U.S. Centers for Disease Control and Prevention’s National Center for Health Statistics released last year indicated there was a 15% increase in overdose deaths in 2021 compared to 2020 and a 30% increase from 2019 to 2020.
To learn more about the fentanyl crisis and ways to keep our young people safe, watch our KNX News Town Hall here.
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