On Wednesday, independent advisers to the Food and Drug Administration unanimously recommended the use of over-the-counter Narcan nasal spray to reverse opioid overdoses, which would dramatically expand access to lifesaving treatment.
Emerging BioSolutions‘Narcan is the most commonly sold treatment for opioid overdose. The FDA is expected to make a decision by March 29 on whether to allow people to buy the four-milligram nasal spray without a prescription. The agency is not required to accept the recommendation of its advisers, although it usually does.
“There’s no reason to keep this as a prescription, let’s get it out there and save lives,” said Elizabeth Coykendall, paramedic at PM Pediatrics in Raleigh, North Carolina and a temporary voting member of the FDA committee.
Emergent BioSolutions said Narcan would be available on the over-the-counter market by the end of the summer if the FDA approves it next month. The company has yet to disclose how much it will cost.
“We’ve been working on distribution plans with key stakeholders like retailers and government leaders,” said company spokesman Matt Hartwig.
Most states have already issued blanket orders that allow pharmacies to dispense Narcan, generically known as naloxone, without the patient having to present a script. But FDA approval of Narcan for over-the-counter use would make it easier for more people to acquire the treatment in more places.
“If naloxone becomes a non-prescription product, it can be sold in many places previously unavailable to consumers, including vending machines, convenience stores, supermarkets and big box stores, just like other non-prescription products “said Jody Green, the FDA’s non-prescription drug manager. division, the advisory committee said Wednesday.
Since 1999, more than 564,000 people have died from opioids in the United States in three waves — first from prescription opioids, then from heroin and more recently from fentanyl, according to the Centers for Disease Control and Prevention. Opioid overdose deaths have increased by 17% during the pandemic, from around 69,000 in 2020 to nearly 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.
“Every day 187 people will die – this is absolutely tragic because we think not only of the individuals themselves, but also of families, communities, workplaces. It has a profound human impact and we are all affected by it” , Manish Vyas, senior vice president of regulatory affairs at Narcan maker Emergent BioSolutions, told the committee.
Scott Hadland, head of adolescent medicine at Massachusetts General Hospital, said the widespread infiltration of fentanyl into the country’s drug supply has increased the risk of overdose. Many people exposed to fentanyl take counterfeit pills they thought were prescribed but actually contain the very potent and often deadly opioid, Hadland said.
“And increasingly, there are second-hand exposures that are also increasing,” Hadland, who participated in the Emergent BioSolutions presentation, told the committee. “We are seeing an increase in overdose deaths in toddlers who encounter fentanyl in public places or fentanyl that may be elsewhere in the home.”
Hadland said he told parents to keep Narcan at home in case of an emergency. He compared it to a fire extinguisher that families should have for safety but hopefully never have to use.
“Unfortunately for most young people, families and community members across the country, current pathways are difficult,” Hadland said.
Dr Bobby Mukkamala of the American Medical Association said Narcan should be as easy to get as Tylenol for a headache or a decongestant for a stuffy nose. Narcan should be just as common in public places as AED devices used to treat people with heart attacks, Mukkamala said.
Jessica Hulsey, executive director of the Addiction Policy Forum, told the committee in a public comment section that Narcan should be offered at an affordable price of no more than $20 per dose if sold without a prescription. This is because Narcan is packaged in single doses, and multiple doses may be needed to reverse an overdose of high-potency fentanyl, Hulsey said.
Narcan displaces opioids that bind to receptor sites in a person’s nervous system. By displacing and blocking opioids, the nasal spray prevents fatal overdoses by reversing respiratory depression, said Gay Owens, head of global medical affairs at Emergent BioSolutions.
But Narcan should be given as soon as an overdose is suspected, which is why it’s crucial to make sure the nasal spray’s instructions for use are simple, the FDA’s Green said. FDA advisers wondered how to make the instructions on Narcan’s box as clear as possible so that anyone could easily use the device in a life-threatening emergency.
In a study sponsored by Emergent BioSolutions, over 90% of 71 participants understood over-the-counter label instructions and correctly used the Narcan device during a simulated overdose emergency using dummies. Participants included people with varying levels of literacy and adults and adolescents.
But some attendees were confused by the five-step instructions because they were spread across the side and back panels of the carton, said Millie Shah, senior pharmacist at the FDA’s division that monitors errors in drug administration. This confusion could lead to a delay in administration or errors in the correct use of the Narcan device when time is of the essence, according to Shah.
These cases occurred despite the participants having had as much time as needed to familiarize themselves with Narcan’s instructions, which may not be the case in an actual overdose emergency, according to Shah.
“Therefore, the data collected does not reflect this high-risk usage scenario,” Shah said.
The FDA proposed that Emergent BioSolutions place the five instructions in sequential order on the back panel of the carton and also include the instructions in the device’s blister pack. The company presented a mock-up at the advisory meeting, but the FDA said it has not yet evaluated it.
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