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The Food and Drug Administration on Wednesday approved the sale of over-the-counter Narcan nasal spray to reverse opioid overdoses, a decision that promises to significantly expand access to the life-saving treatment.
The FDA’s decision means people will be able to buy the 4-milligram nasal spray in supermarkets, convenience stores, gas stations, vending machines and online. Emergent biosolutionsmanufacturer, said Narcan should be available over the counter by late summer.
FDA Commissioner Dr. Robert Califf said in a statement that the agency is encouraging the company to make the nasal spray available at an affordable price as soon as possible.
Narcan reverses fatal overdoses by blocking the effect that opioids have on the nervous system. The nasal spray should be used as soon as an overdose is suspected.
There are usually two nasal sprays in one pack. The first dose should be given in one nostril of the person having an overdose, and then 911 should be called as directed. If the person is still unresponsive after two to three minutes, a second dose should be given.
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The FDA said in November that it was considering approving products containing naloxone, the generic name for opioid overdose reversal drugs, for over-the-counter use. The effort to make naloxone easier to access is part of the FDA’s efforts 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.
Between 1999 and 2020, more than 564,000 people died from opioid overdoses, 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-related deaths since 2010.
Deaths from synthetic opioids such as fentanyl have increased significantly since 2013. More than 71,000 people died from synthetic opioids in 2021, an 18 percent increase from the year before.
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