FDA approves over-the-counter Narcan to reduce drug overdoses

(NEW YORK) — The U.S. Food and Drug Administration approved the overdose reversal drug Narcan for over-the-counter use on Wednesday — a milestone decision that advocates said will make it easier to save lives amid the ongoing opioid epidemic.

Narcan, made by the company Emergent BioSolutions, is given as a nasal spray and the active ingredient in the medication — naloxone — can quickly restore breathing if someone is experiencing an opioid overdose.

Medical experts said it is safe for bystanders to administer the drug to anyone who appears to be experiencing an overdose and will not hurt users if it turns out they are not experiencing an overdose.

The FDA’s approval means the medication can now be sold to Americans in places such as drug stores, grocery stores, convenience stores, gas stations and even online.

“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country,” FDA Commissioner Dr. Robert M. Califf said in a statement. “We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

The drug is already available in a prescription form — although state laws made it possible for people to obtain it without a prescription through various workarounds.

In November, the FDA encouraged drug companies to submit applications for over-the-counter versions of naloxone.

The U.S. has been battling a drug overdose epidemic for years. According to provisional data from the Centers for Disease Control and Prevention, there were an estimated 107,622 drug overdose deaths in the U.S. in 2021 — a record-high.

The majority of these deaths were due to opioids, particularly synthetic opioids such as fentanyl, which is between 50 and 100 times stronger than morphine.

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