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FDA panel recommends making opioid overdose antidote available over the counter

The agency is expected to reach a final decision by late March.
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A drug that can rapidly reverse opioid overdoses could soon be available to anyone without a prescription.

A Food and Drug Administration advisory committee on Wednesday voted unanimously to recommend that the agency allow a nasal spray version of naloxone, from Emergent Biosolutions, to be sold over the counter. 

Naloxone, also sold under the brand name Narcan, is a medication that has been used for decades to quickly reverse the effects of an overdose from opioids, including prescription painkillers, as well as heroin and fentanyl. In November, the FDA asked drug companies that make naloxone to apply for over-the-counter approval.

Committee members said the move would save lives.

“For the sake of the public and saving lives, I believe this medication should be available over the counter as soon as possible,” Dr. Katalin Roth, a professor of medicine at the George Washington University School of Medicine and Health Sciences, said following the vote.

Drug overdoses are currently the leading cause of accidental deaths in the United States, according to the Centers for Disease Control and Prevention, killing more than 107,000 people in 2021. More than 80,000 of those deaths involved opioids.

"The risk of opioid overdose is far too great to prevent the drug from the OTC market," said Jennifer Higgins, the director of grants at the Center for Human Development, a nonprofit that provides community health services in Springfield, Massachusetts.

Currently, naloxone is offered only as a prescription medication, however, many states have created workarounds that allow people to get the drug directly from pharmacists. It can also often be found at community centers, local health departments and needle exchange programs.  

Still, not all pharmacists keep the medication in stock and some patients may be shy about interacting with a pharmacist, Dr. Jody Green, an FDA official, said during Wednesday's meeting. And community centers that offer patients naloxone for free often have limited supply, she added.

The panel’s recommendation will now go to the FDA, which is expected to make a final decision by March 29. If the agency follows through on the approval, the drug could be sold in places like convenience stores, grocery stores — even vending machines.

As overdoses have become more common, so have prescriptions for naloxone: The number of naloxone prescriptions increased from about 359,000 in 2017 to 1.5 million in 2021, according to briefing documents published by the FDA.

Over-the-counter nasal spray

The version of naloxone being considered for over-the-counter use is a single 4 milligram dose, given as nasal spray. It’s been approved since 2015 for the emergency treatment of known or suspected opioid overdoses in people of all ages, including children.

On Wednesday, most committee members agreed that naloxone was safe to use without medical supervision. The most common side effects after using the drug were related to opioid withdrawal, according to a presentation at the meeting. If given to someone not experiencing an opioid overdose, the drug will have no effect.

Most concerns were instead about the drug’s instruction label and how easy it is to use.

Ease of use is particularly important for young children because they may have to administer the medication to a parent and another loved one who has overdosed, Dr. Leslie Walker, the department chair of pediatrics at the University of Washington, said.

Most people do use the naloxone correctly, though errors like spraying the medication into the air, instead of the nose, or not waiting the recommended two to three minutes before giving another dose, sometimes do happen. 

Some people did not keep the device fully inserted in the nose during use, according to the agency, while others held the device upside down. 

In an effort to make the nasal spray easier to use, Emergent representatives proposed a new label with a bright red background and black, bold lettering. It carries instructions on how to use the medication as well as the appropriate steps one should take after administering naloxone, including calling 911.

Other panel members said they had concerns about supply issues because people could use it incorrectly, wasting doses.

Elizabeth Coykendall, a patient representative from WakeMed Children's PM Pediatrics Urgent Care in North Carolina, however, was confident that people could properly administer the medication.

“Giving them Narcan over the counter will give them more opportunity to stay alive," she said.

CORRECTION (Feb. 15, 2023, 5:46 p.m. ET): A previous version of this article misstated the day the FDA advisory committee meeting took place. It was Wednesday, not Thursday.

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