The opioid overdose reversal drug naloxone may be safe and effective for use without a prescription in some forms, the US Food and Drug Administration (FDA) said Tuesday, potentially paving the way for its use at the federal level.
The FDA would still require data on individual products from manufacturers to make them available without a prescription at the federal level.
The drug regulator’s preliminary evaluation included a dose of up to 4 milligrams of naloxone nasal spray and up to 2 milligrams when administered via auto-injector.
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The agency said the assessment does not cover higher-dose naloxone products and those supplied in other forms for which more data was needed.
Currently, doctors can prescribe the antidote, which can save lives when given early, if patients are taking high doses of opioids. It is also available in some states without a prescription or through community programs.
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More than 16,000 people have died from prescription opioid overdoses in 2020, according to government data.