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FDA approves naloxone nasal spray for over-the-counter use

A red Narcan nasal spray dispenser in a park.
Sam Searles
A Narcan dispenser in McPherson Square park in Philadelphia's Kensington neighborhood.

On Wednesday, the U.S. Food and Drug Administration announced that naloxone, a life-saving medication that reverses the effects of opioid overdose, was approved for over-the-counter use, without the need for a prescription, for up to four milligrams.

Public health advocates and harm reduction proponents in Philadelphia have long fought to make the medication more accessible. Like most states, Pennsylvania law requires a prescription, but pharmacists can do standing orders, which allows dispensing without an individual prescription.

Jose Benitez, lead executive officer at Prevention Point Philadelphia, told the Associated Press Wednesday that “putting it out on the shelves is going to allow people just to pick it up, not have stigma attached to it.”

Naloxone, often referred to by its name brand Narcan, is primarily administered as a nasal spray, which helps restore repressed breathing from opioid use.

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FDA Commissioner Robert M. Califf said in a statement the approval addresses the “evolving complexities of the overdose crisis,” adding it will expand access to the medication nationwide.

“The agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” Califf said.

Patrizia Cavazzoni, the director of drug evaluation and research for the FDA, said that the agency would work with federal partners to increase access to naloxone during this transition period.

“We will work with any sponsor seeking to market a non-prescription naloxone product, including through an Rx to over-the-counter switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions,” he said.

Earlier this month, the agency, along with the Drug Enforcement Administration, announced that it was taking action to prevent unlawful imports of xylazine — an animal tranquilizer prevalent in mixtures of fentanyl.

Xylazine, or “tranq,” a substance prevalent in Philadelphia, has been linked to growing drug overdoses and irreversible injuries that have resulted in some amputations. Naloxone is not effective in reversing the effects of xylazine.