FDA approves over-the-counter sales of opioid overdose drug naloxone

COLUMBIA, Mo. (KMIZ)

The FDA approved a 4-milligram naloxone nasal spray for over-the-counter sales Wednesday.

Naloxone, also known by its brand name Narcan, is a medication that quickly reverses an opioid overdose. Naloxone is a standard treatment for overdoses in the field and is often carried by first responding agencies.

"This is a life-saving medication," Dr. Chris Sampson, an emergency department physician with MU Health Care, said. "If anyone is suffering from an opioid overdose, it often helps them recover, sometimes from death."

Dr. Sampson said that Narcan won't have a negative effect on someone if they're not experiencing an opioid overdose.

"There's not a harm to it," Sampson said. "If it's a different situation and someone doesn't know if it's an opioid overdose and it's another medical condition, that's still okay."

This now-approved medication will now be available for purchase at local places such as pharmacies, convenience stores, grocery stores, gas stations and online stores.

Although the medication is now FDA-approved, the timeline of availability for the medication comes down to the manufacturers.

The switch from prescription Narcan to over-the-counter sales may take months.

The FDA granted approval of over-the-counter Narcan to Emergent BioSolutions.

Different variations and dosages of the drug will remain prescription only.

To change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective to use by simply following directions on the package.

The manufacturer showed that consumers can understand how to use the drug safely without the help of a health-care professional. 

The application to approve Narcan was the subject of an advisory committee meeting last month, where committee members unanimously approved the drug for marketing without a prescription. 

Sampson said although Narcan is extremely helpful, it is not the final treatment for someone overdosing.

"You should probably be calling 9-1-1 and having them be evaluated by EMS and likely be taken to the hospital," Sampson said. "Again, there's so many types of opioids and some have lengths of effect that it could require additional doses of naloxone or narcan, it could require extended monitoring in the hospital."

According to the Missouri Department of Health and Senior Services, the age group most at risk to die from an opioid-related death is 25-34. In 2021, 467 Missourians died of an opioid-related overdose.

There were 1,581 opioid-related deaths in Missouri in 2021. This both encapsulates heroin and non-heroin-related deaths. The state reported 35.07 overdose deaths per 100,000 people in Missouri in 2021.

Narcan was first approved for prescription use by the FDA in 2015.