Advisers to the FDA will meet to discuss whether a nasal spray version of the opioid overdose antidote Narcan should be made available over-the-counter.
The Baltimore-area company Emergent BioSolutions Inc. submitted an application to the FDA late last year to be allowed to sell generic naloxone hydrochloride without a prescription, the first such application for a naloxone spray. Emergent’s application was granted priority review after the FDA signaled that it would support submissions to improve access to the lifesaving medication.
All 50 states, the District of Columbia and Puerto Rico have laws that allow naloxone to be sold without prescription at a pharmacy, but it still must be bought from a pharmacist. Many pharmacies don’t carry the product, in part due to issues related to its prescription status, the FDA said in briefing documents. Making naloxone available without a prescription may also clear up some confusing legalities that could make nonpharmacy programs reluctant to distribute it, Evoy said.
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