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The Epoch Times
The Epoch Times
29 Mar 2023


NextImg:FDA Approves Opioid Overdose Drug Narcan for Over-the-Counter-Sales

Narcan, a drug that can reverse the effects of an opioid overdose, has received federal approval to be sold without a prescription at pharmacies throughout the United States.

The nasal spray form of Narcan, made by Maryland-based company Emergent BioSolutions, was first approved by the U.S. Food and Drug Administration (FDA) in 2015 as a prescription drug. Its active ingredient, naloxone, is a compound that binds to opioid receptors in the brain and reverses the potentially fatal effects of opioid intoxication, such as coma and respiratory depression.

In an announcement on Wednesday, the FDA said Americans can now buy the life-saving medication over the counter in places like drug stores, convenience stores, grocery stores, and gas stations, as well as 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,” said FDA Commissioner Dr. Robert Califf. “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.”

Naloxone comes in different forms on the market, and the nasal spray version can be administered by both trained and untrained users. With some professional training, it can also be injected into the muscle, under the skin, or into the veins.

There is also an auto-injection version of naloxone, sold under brand name Evzio. It’s a pre-filled device that any untrained user can inject into the patient’s outer thigh, similar to EpiPen commonly used to treat allergic reactions.

According to the FDA, the approval of Narcan will require a change in labeling for generic naloxone nasal spray products, and manufacturers will be required to submit a supplement to their applications so they can receive OTC status.

In the meantime, the FDA will review other brand-name naloxone nasal spray products on a case-by-case basis.

Prior to Wednesday’s OTC approval, all 50 states and the District of Columbia have enacted some form of legal workarounds that make it possible for people to obtain naloxone without a prescription. In states like New York and Pennsylvania, police officers, firefighters, and emergency medical personnel are trained to use and encouraged to carry naloxone with them to help prevent deaths.

Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, the FDA said. The deadly opioid epidemic is primarily driven by synthetic drugs like fentanyl, which is 100 times stronger than morphine and 50 times stronger than heroin.