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FDA approves over-the-counter sales of Narcan nasal spray

The Food and Drug Administration on Wednesday approved the nonprescription sale of Narcan nasal spray to reverse opioid overdoses, a move that promises to dramatically expand access to the lifesaving treatment.

The FDA’s decision means people will be able to buy the 4-milligram nasal spray at supermarkets, convenience stores, gas stations, vending machines and online. Emerging BioSolutionsthe manufacturer, said Narcan should be available without a prescription by the end of the summer.

FDA Commissioner Dr. Robert Califf said in a statement that the agency encourages the company to make the nasal spray available at an affordable price as soon as possible.

Narcan reverses fatal overdoses by blocking the effect of opioids on the nervous system. The nasal spray should be administered as soon as an overdose is suspected.

Two nasal sprays usually come in one package. The first dose should be administered into one nostril of the overdose person, then 911 should be called, as instructed. If the person still does not respond after two to three minutes, the second dose should be given.

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The FDA said in November it was considering approving naloxone products, the generic name for drugs that reverse opioid overdoses, for use without a prescription. The move to make naloxone easier to access is part of the FDA’s efforts to address the opioid crisis.

The Trump administration first declared the opioid epidemic a public health emergency in 2017. The Biden administration renewed the public health emergency every 90 days.

More than 564,000 people died from an opioid overdose between 1999 and 2020, according to the Centers for Disease Control and Prevention. The first wave of the epidemic began in the 1990s with prescription opioids, followed by an increase in heroin deaths from 2010.

Deaths from synthetic opioids such as fentanyl have risen dramatically since 2013. More than 71,000 people died from synthetic opioids in 2021, an 18% increase from the previous year, according to CDC estimates.


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