Advisers to the Food and Drug Administration recommended Wednesday that an opioid overdose reversal drug should be made available over the counter for the first time.
The Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee voted unanimously that Emergent BioSolutions’s naloxone nasal spray, also known as Narcan, should be allowed to be sold without a prescription, removing barriers to accessing the antidote that health experts suggested would save more lives.
VENDING MACHINES FOR ANTI-OVERDOSE DRUG NARCAN GAIN SUPPORT
“The safety of Narcan nasal spray has been very well established. There appear to be very minimal risks, if any, in terms of unintended effects or unintended serious effects that are worse than the alternative of not treating a patient,” said Maria Coyle, chairwoman of the Nonprescription Drugs Advisory Committee. “We, as a committee, appear to be in support of the safety profile.”
The FDA first approved injectable naloxone in the 1970s to treat overdoses. In 2015, the Narcan nasal spray was made available on a prescription basis, though all 50 states and the District of Columbia have laws that allow Narcan to be sold without a prescription.
Federal rules still require that Narcan be bought from a pharmacist, which the FDA said has led many pharmacies not to carry it. If it is allowed over the counter, it could then be sold at vending machines, convenience stores, and supermarkets.
FDA advisers expressed broad support for moving forward with making Narcan nasal spray more widely, noting that they saw minimal risks for it being available without a prescription. Some advisers brought up suggestions, though, for improvements in its labeling.
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The advisory group’s recommendation is not binding, and it will be up to FDA to make a final call in the coming weeks.
In 2021, drug overdose deaths surpassed 108,000, a record high, with 75% involving at least one opioid, fueled largely by the potent synthetic opioid fentanyl, according to the Centers for Disease Control and Prevention.
