FDA clears Narcan nasal spray for sale over-the-counter to treat life-saving opioid overdose

The Food and Drug Administration on Wednesday approved the over-the-counter nasal spray Narcan to help reverse opioid overdoses, a decision that promises to greatly expand access to the life-saving treatment.

The FDA’s decision means people can buy the 4-milligram nasal spray at supermarkets, convenience stores, gas stations, vending machines and online. Emerging biosolutionsthe manufacturer, has said Narcan should be available without a prescription by late summer.

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

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

Two nasal sprays usually come in a single pack. The first dose should be administered into one nostril of the person suffering from an overdose and then 911 should be called according to the instructions. 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 that it was considering allowing naloxone products, the generic name for drugs that reverse opioid overdoses, for use without a prescription. The push to make naloxone more accessible is part of the FDA’s effort to combat the opioid crisis.

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

More than 564,000 people died from opioid overdoses 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 a spike in heroin-related deaths from 2010.

Deaths from synthetic opioids such as fentanyl have increased significantly since 2013. The CDC estimates that more than 71,000 people will die from synthetic opioids in 2021, an 18% increase from the previous year.

Source : www.cnbc.com

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