FDA panel approves making naloxone over the counter

Jessie Blanchard’s jeep bumper holds a sticker with the slogan “Yes We Narcan” on Monday, Jan. 23, 2023, in Albany, Ga. (AP Photo/Brynn Anderson)

(NewsNation) — A panel of Food and Drug Administration experts recommended the drug naloxone, which is used to reverse opioid overdoses, be made available over the counter.

On Wednesday, the panel voted unanimously in favor of the switch, although this vote is not binding.

Currently, the drug is only available by prescription. Narcan is the leading version of naloxone in the U.S. and is available as a prefilled nasal device and injection.

NewsNation partner The Hill reports that this medication being prescription-only has been a major barrier to access. Although The Hill noted that every state has “standing orders” that are intended to make the drug available without one, not all pharmacies carry it, and it can be a complicated process.

The FDA will make a final decision on making naloxone an over-the-counter drug by March 29, although some panel members want to see it happen sooner, The Hill reports.

“There’s perhaps a far greater risk of delaying the availability of the product given the climate of this crisis and its devastating consequences,” said Maria Coyle, a pharmacy professor from Ohio State University, who chaired the panel.

There were some concerns about Narcan’s instructions and packaging, as some people in a company study found them confusing. Emergent Biosolutions, which manufactures the drug, said it would revise the packaging to address this.

Should the FDA approve the panel’s suggestion, Narcan would be the first opioid treatment to make a regulatory switch to a non-prescription drug.

“There’s no reason to keep this as a prescription. Let’s get it out there and save some lives,” said Elizabeth Coykendall, a paramedic in North Carolina and a temporary voting member of the panel, according to the Hill.

Although the opioid epidemic has been a problem for a while, in recent years, it has been exacerbated by the COVID-19 pandemic. The creation and reemergence of powerful synthetic opioids has also caught officials’ attention. Of the 107,375 people in the U.S. who died of drug overdoses and poisoning in the 12-month period ending in January 2022, 67% of them involved synthetic opioids, according to the Drug Enforcement Administration.

Although the rate of drug overdoses slightly decreased from July 2021 to July 2022, the number of overdose deaths connected to fentanyl has continued to rise at an alarming rate. A new report from the nonprofit Families Against Fentanyl found deaths of children under 14 from fentanyl poisoning are surging as well.

The Associated Press contributed to this report.


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