Independent advisors to the Food and Drug Administration on Wednesday unanimously recommended the over-the-counter use of the nasal spray Narcan to reverse opioid overdoses, which would expand access to the life-saving treatment.
emergency bio solutionNarcan is the best-selling treatment for opioid overdose. The FDA is expected to make a decision by March 29 on whether to allow people to buy the 4 mg nasal spray without a prescription. The agency is not required to accept the recommendation of its advisors, although it usually does so.
“There’s no reason to keep this out as a prescription, let’s get it out there and save some lives,” said Elizabeth Coykendall, a paramedic at PM Pediatrics in Raleigh, North Carolina, and a temporary voting member of the FDA committee. .
Emergent BioSolutions said Narcan would be available for the over-the-counter market by late summer if the FDA approves it next month. The company has not yet revealed how much it will cost.
“We are working on distribution plans with key stakeholders such as retailers and government leaders,” said Matt Hartwig, a spokesman for the company.
Most states already issue blanket prescriptions that allow pharmacies to dispense Narcan, known generically as naloxone, without presenting a script to the patient. But FDA approval of Narcan for over-the-counter use will allow more people in more places to get treatment more easily.
“If naloxone becomes a nonprescription product, it could be sold in many places that were not previously available to consumers, including vending machines, convenience stores, supermarkets, and big box stores, along with other nonprescription products. Kind of,” Jody Green, an official in the FDA’s nonprescription drug division, told the advisory committee on Wednesday.
According to the Centers for Disease Control and Prevention, more than 564,000 people in the US have died from opioids in three waves since 1999 — first from prescription opioids, then from heroin and most recently from fentanyl. Opioid overdose deaths increased by 17% during the pandemic from about 69,000 in 2020 to about 81,000 in 2021.
The Trump administration first declared the opioid epidemic a public health emergency in 2017. The Biden administration has renewed the emergency declaration every 90 days since the President took office.
Manish Vyas, senior vice president of regulatory affairs at Narcan maker Emergent BioSolutions, told the committee.
Scott Hadland, chief of adolescent medicine at Massachusetts General Hospital, said the widespread infiltration of fentanyl into the nation’s drug supply has increased the risk of overdose. Hadland said many people who are exposed to fentanyl take counterfeit pills they think were prescribed, but are actually highly potent and often deadly opioids.
“And increasingly chronic exposures are on the rise as well,” Hadland, who attended the presentation by Emergent BioSolutions, told the committee. “We are seeing overdose deaths among children who are exposed to fentanyl in public places or fentanyl that may be elsewhere in the home.”
Hadland said he tells parents to keep Narcan at their home in case of emergency. He compared it to a fire extinguisher that families should have for safety reasons but will hopefully never have to use.
“Unfortunately for most young people, families and community members across this country, existing pathways to access are challenging,” Hadland said.
Dr. Bobby Mukkamala of the American Medical Association said Narcan should be as easy to obtain as Tylenol to treat a headache or a stuffy nose. Narcan should be as common in public places as the AED devices that are used to treat heart attack victims.
Jessica Hulsey, executive director of the Addiction Policy Forum, told the committee during a public comment section that Narcan need not cost more than $20 per dose if sold over the counter. Narcan is packaged as a single dose and may take multiple doses to reverse an overdose from the highly potent fentanyl.
Narcan displaces opioids that have attached to receptor sites in a person’s nervous system. By displacing and blocking opioids, the nasal spray prevents fatal overdose by reversing respiratory depression, said Gay Owens, head of Global Medical Affairs at Emergent BioSolutions.
The FDA’s Green said Narcan should be administered as soon as an overdose is suspected, which is why it’s important to make sure the instructions for using the nasal spray are simple. FDA consultants were considering how to make the instructions on Narcan cartons as clear as possible so that anyone could easily use the device in an emergency.
In a study sponsored by Emergent BioSolutions, more than 90% of 71 participants understood over-the-counter label directions and correctly used a NARCAN device during a simulated overdose emergency using mannequins. The participants included people with varying levels of literacy and both adults and adolescents.
But some participants were confused by the five-step instructions because they were divided into side and back panels of the carton, said Millie Shah, senior pharmacist in the FDA division that monitors drug administration errors. According to Shah, this confusion can result in delayed administration or errors in using the Narcan device correctly.
These instances occurred despite the fact that participants were given as much time as necessary to familiarize themselves with Narcan instructions, which, according to Shah, may not be the case in a real-world overdose emergency.
“Therefore, the data collected does not capture this highest-risk usage scenario,” Shah said.
FDA has proposed that Emergent BioSolutions place all five instructions in sequential order on the back panel of the carton and also include the instructions in the device blister pack. The company presented a mockup at the consultative meeting, but the FDA said it is yet to evaluate it.