FDA could approve OTC nasal spray to treat overdoses

Health

(NewsNation) — The U.S. Food and Drug Administration may approve over-the-counter nasal sprays that prevent overdoses in part of its efforts to expand access to the life-saving drug naloxone.

If approved this spring, officials are hopeful it could help solve the fentanyl epidemic.

Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner, said he thinks a year is a good timeline for the FDA to test this product, and that’s more or less what the FDA has committed to.

“Another thing we’ve got to recognize is access goes beyond moving from prescription to over-the-counter. One of the issues with over-the-counter is that health insurance generally does not cover it,” Pitts said. “So we have to be sure that even though the product might be available off the shelf, without the need for a prescription or the aid of a pharmacist, people might have problems affording it. Which is why it’s important to make sure these manufacturers have the public health first in mind.”

Overdose death rates rose by 14% in 2021 compared to 2020, driven mainly by the illegal synthetic opioid fentanyl, according to data from the Centers for Disease Control and Prevention. According to the report, there was a 22% increase in overdose deaths from synthetic opioids in 2021.

Pitts said this over-the-counter nasal spray is safe and effective and would help in any emergency. He also said he disagrees with some who argue that the spray is condoning opioid abuse.

“I don’t buy that argument. Getting an opioid overdose is a situation that nobody ever wants to face. It’s kind of like saying that giving people fire deterrent materials will allow them to be artists. I think it’s important that people have access to this drug to have open access to this drug, regardless of any of the potential silly arguments,” Pitts said.

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