FDA Approves Over-the-Counter Narcan for Opioid Overdose Prevention

“The U.S. Food and Drug Administration (FDA) approved the sale of naloxone without providing a prescription, setting the overdose-reversing medicine on course to become the first treatment drug for opioids to be sold through the counter.”

The U.S. Food and Drug Administration (FDA) approved the sale of naloxone without providing a prescription, setting the overdose-reversing medicine on course to become the first treatment drug for opioids to be sold through the counter.

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This measure has been taken to enhance access to life-saving medication, though the exact impact will not be clear immediately.

WHAT IS NARCAN?

NARCAN is the best-known form of naloxone and an approved branded nasal spray manufactured by Emergent BioSolutions based in Maryland.

Naloxone has the capability to reverse overdoses of opioids including street medicine like fentanyl, heroin, and prescription versions of oxycodone.

Making naloxone widely accessible is being considered a key strategy to control the nationwide overdose crisis, which has caused over 100,000 deaths a year in the U.S. Most deaths have been because of opioids, primarily potent synthetic versions like fentanyl that can take multiple doses of naloxone to reverse.

Experts believe it’s significant to get Naloxone to people who may take overdoses of opioids, including those who use drugs and their similar versions.

WHAT DOES THE FDA APPROVAL MEAN?

Emergent BioSolutions said naloxone i.e. Narcan will be available at the counter by late summer.

Other versions of naloxone and injectable forms will still take time to be available over the counter. 

Harm Reduction Therapeutics Inc., a nonprofit organization backed by Purdue Pharma, the OxyContin maker, has applied before the FDA to distribute its version of spray naloxone without a prescription.