The Food and Drug Administration’s independent advisors on Wednesday unanimously recommended over-the-counter use of the nasal spray Narcan to reverse opioid overdoses, which would significantly expand access to the life-saving treatment.
Emergent BioSolutions‘ Narcan is the most commonly sold treatment for opioid overdoses. 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 its advisors recommendation, though it typically does so.
“There is no reason to keep this 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 disclosed how much it would cost.
“We have been working on distribution plans with key stakeholders like retailers and government leaders,” said Matt Hartwig, a spokesperson for the company.
Most states have already issued blanket prescriptions that allow pharmacies to distribute Narcan, generically 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 acquire the treatment more easily in more places.
“If naloxone becomes a nonprescription product, it may be sold in many venues previously unavailable to consumers, including vending machines, convenience stores, supermarkets and big box stores, just like other nonprescription products,” Jody Green, an official at the FDA’s nonprescription drug division, told the advisory committee Wednesday.
Since 1999, more than 564,000 people have died from opioids in the U.S. in three waves — first from prescription opioids, then from heroin and most recently from fentanyl, according to the Centers for…
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