The Food and Drug Administration’s independent advisors on Wednesday unanimously really useful over-the-counter use of the nasal spray Narcan to reverse opioid overdoses, which might significantly expand access to the life-saving treatment.
Emergent BioSolutions‘ Narcan is probably the most commonly sold treatment for opioid overdoses. The FDA is predicted to make a choice by March 29 on whether to permit people to purchase the 4 milligram nasal spray with out a prescription. The agency isn’t required to just accept its advisors suggestion, though it typically does so.
“There is no such thing as a reason to maintain this as a prescription, let’s get it on the market and avoid wasting lives,” said Elizabeth Coykendall, a paramedic at PM Pediatrics in Raleigh, North Carolina and a short lived voting member of the FDA committee.
Emergent BioSolutions said Narcan could be available for the over-the-counter market by late summer if the FDA approves it next month. The corporate has not yet disclosed how much it will cost.
“Now we have been working on distribution plans with key stakeholders like retailers and government leaders,” said Matt Hartwig, a spokesperson for the corporate.
Most states have already issued blanket prescriptions that allow pharmacies to distribute Narcan, generically often known as naloxone, without the patient having to present a script. But FDA approval of Narcan for over-the-counter use would allow more people to accumulate the treatment more easily in additional places.
“If naloxone becomes a nonprescription product, it could be sold in lots of venues previously unavailable to consumers, including vending machines, convenience stores, supermarkets and massive box stores, similar to other nonprescription products,” Jody Green, an official on the FDA’s nonprescription drug division, told the advisory committee Wednesday.
Since 1999, greater than 564,000 people have died from opioids within the U.S. in three waves — first from prescription opioids, then from heroin and most recently from fentanyl, in accordance with the Centers for Disease Control and Prevention. Opioid overdose deaths spiked 17% throughout the pandemic from about 69,000 in 2020 to almost 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 because the president took office.
“Every day 187 people will die — this is completely tragic as we predict of not only the individuals themselves, however the families, the communities, the workplaces. This has profound human impact and we’re all impacted from this,” Manish Vyas, senior vp 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 nation’s drug supply has increased the danger of overdoses. Many people who find themselves exposed to fentanyl take counterfeit pills that they thought were prescribed but actually contain the highly potent and infrequently deadly opioid, Hadland said.
“And increasingly there are secondhand exposures which might be also rising,” Hadland, who participated in Emergent BioSolutions’ presentation, told the committee. “We’re seeing rising overdose deaths amongst toddlers who’re coming across fentanyl in public settings or fentanyl which may be elsewhere in the house.”
Hadland said he tells parents to maintain Narcan at their home in case of an emergency. He compared it to a hearth extinguisher that families must have for safety reasons but hopefully won’t ever must use.
“Unfortunately for many young people, families and community members all across this country, current avenues of access are difficult,” Hadland said.
Dr. Bobby Mukkamala of the American Medical Association said Narcan needs to be as easy to acquire as Tylenol to treat a headache or a decongestant for a stuffy nose. Narcan needs to be just as common in public places as AED devices which might be used to treat people affected by heart attacks, Mukkamala said.
Jessica Hulsey, executive director of the Addiction Policy Forum, told the committee during a public comment section that Narcan must be priced affordably at not more than $20 per dose if it’s sold over-the-counter. It’s because Narcan is packaged as single doses and it may possibly take multiple doses to reverse an overdose from highly potent fentanyl, Hulsey said.
Narcan displaces opioids that bind to receptor sites in an individual’s nervous system. By displacing and blocking opioids, the nasal spray prevents fatal overdoses by reversing respiratory depression, said Gay Owens, head of world medical affairs at Emergent BioSolutions.
But Narcan needs to be administered as soon as an overdose is suspected, which is why it’s crucial to make sure that the instructions for using the nasal spray are easy, the FDA’s Green said. The FDA’s advisors grappled with the right way to make the instructions on the Narcan carton as clear as possible so anyone can use the device with ease in a life-threatening emergency.
In a study sponsored by Emergent BioSolutions, greater than 90% of 71 participants understood over-the-counter label directions and used the Narcan device accurately during a simulated overdose emergency using mannequins. The participants included individuals with various levels of literacy and each adults and adolescents.
But some participants were confused by the five-step instructions because they were split across the side and back panels of the carton, said Millie Shah, senior pharmacist on the FDA division that monitors errors in administering medicine. This confusion could lead to delayed administration or errors in using the Narcan device accurately when time is of the essence, in accordance with Shah.
These instances occurred despite the undeniable fact that the participants were allowed as much time as needed to familiarize themselves with the Narcan instructions, which might not be the case in a real-world overdose emergency, in accordance with Shah.
“Due to this fact, the information collected doesn’t capture this highest-risk use scenario,” said Shah.
The FDA has proposed that Emergent BioSolutions place all five instructions in sequential order on the back panel of the carton and in addition include instructions within the device blister pack. The corporate presented a mockup on the advisory meeting, however the FDA said it has not evaluated it yet.