FDA Panel Backs Shifting Opioid Antidote Over the Counter – NBC Bay Space
The overdose-reversal drug, naloxone, should be available as an over-the-counter drug to help the national response to the opioid crisis, U.S. health advisers said Wednesday.
The Food and Drug Administration panel of experts voted 19-0 in favor after a full day of presentations and discussions addressing whether untrained users would be able to use the drug, formulated as a nasal spray, safely and effectively in emergency situations the change.
The positive vote, which is non-binding, came despite concerns from some panel members about the drug’s directions and packaging, which caused confusion among some people in a company study.
The manufacturer, Emergent Biosolutions, said it will revise the packaging and labeling to address these concerns. The FDA will make a final decision on the drug in the coming weeks.
Panel members urged the FDA to act quickly instead of waiting for Emergent to conduct a follow-up study with the easier-to-understand label.
Ninety-one people in the US die from opioid-related overdoses every day, but there is a tool that can reverse the effects of an overdose that more law enforcement and paramedics are carrying as part of their ongoing surgical protocol. It’s called Narcan, and here’s what you need to know about what it is, how it works, and how to use it.
“Given the climate of this crisis and its devastating consequences, there may be a much greater risk of delaying product availability,” said Maria Coyle, a pharmacy professor at Ohio State University who chaired the meeting.
The Narcan pre-filled nasal device is the leading version of the drug in the US, which is also available as an injection. If approved by the FDA, Narcan would be the first opioid treatment to make the regulatory switch to an over-the-counter drug.
The potential move represents the government’s recent effort to increase use of a drug that is a key tool in the fight against the US overdose epidemic, which kills more than 100,000 people annually. The decades-old drug can reverse the effects of an opioid overdose in minutes.
Narcan is already available without a prescription in all 50 states, where state leaders have issued standing orders for pharmacists to sell the drug to anyone who asks for it. But not all pharmacies carry it and those that do have to keep it behind the counter. The stigma attached to opioids can also deter people from asking about the drug.
“We believe that over-the-counter naloxone can help break down these barriers,” said Dr. Jody Green of the FDA, noting that the switch would allow the drug to be sold in vending machines, convenience stores and supermarkets.
Emergent presented results from a study of 70 people to show that people of different ages and backgrounds could quickly and correctly understand how to use the device in an emergency. About a third of the study participants had low reading ability, a group that the FDA says should have been larger.
FDA staffers also warned that a number of participants had difficulty following the directions, in part because of the way the multi-step directions were laid out on two sides of the box, the FDA noted.
“Where’s step one?” asked one participant, according to interview transcripts from the study provided by the FDA.
Emergent said it plans to move all directions to a single panel and add pictograms, per the FDA’s proposal.
Government officials are hoping that moving naloxone beyond the pharmacy counter will boost sales, with the potential to reduce costs. Currently, the drug can cost $50 for a two-pack if not covered by insurance.
Community advocates and organizations that support distribution of the drug welcomed the possible approval of an over-the-counter version.
“It’s going to have a tremendous impact on how people view the drug,” said Sheila Vakharia, associate director of research and academic engagement at the Drug Policy Alliance. “It will help destigmatize it and show people that it’s safe and easy to use.”
But Maya Doe-Simkins, a co-director of Remedy Alliance/For The People, worried that an over-the-counter version of narcan could also lead to a perception that it’s better than other forms of naloxone.
“We’re concerned that companies that have over-the-counter products may misrepresent injectable products,” said Doe-Simkins, who has long advocated for an over-the-counter version.
In the 1990s, death rates in the United States from painkillers began to rise steadily. Waves of death followed, led by other opioids such as heroin and, most recently, illicit fentanyl. Nearly 107,000 Americans died from a drug overdose in 2021, an all-time high, although recent data suggest deaths could be plateauing.
Based in Gaithersburg, Maryland, Emergent Biosolutions makes most of its money from medical products purchased by the federal government for the Strategic National Stockpile, including anthrax drugs and vaccines.
In 2021, the company caught public attention for its disastrous handling of COVID-19 vaccine production for Johnson & Johnson and AstraZeneca. Contamination problems at the company’s Baltimore facility eventually forced drugmakers to scrap the equivalent of hundreds of millions of vaccine doses.
Associated Press writer Geoff Mulvihill of Cherry Hill, New Jersey contributed to this story.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.