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FDA Approves Handheld Opiate Antidote

Food and Drug Administration officials on Thursday approved a new handheld device that can quickly deliver a life-saving antidote to addicts who have overdosed on heroin or other opiate drugs.

The device, Evzio, will allow family members or caregivers of addicts to deliver a single dose of the drug naloxone via an auto-injector that can be carried in a pocket or stored in a medicine cabinet, officials said.

It is intended for the emergency treatment of known or suspected opioid overdoses and to prevent overdose deaths, which have tripled in the last decade and now claim some 17,000 lives a year, according to latest figures from the Centers for Disease Control and Prevention.

FDA Compares Evzio to a Defibrillator 2:49

“Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the United States,” Dr. Bob Rappaport of the FDA’s Center for Drug Evaluation and Research said in a statement. “Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations.”

The drug device is made by Kaleo, former known as Intelliject.

Naloxone can rapidly reverse the effects of opioid overdose and is considered standard treatment used by first responders and emergency room doctors. However, until now, the drug has generally had to be administered with a syringe, although it is also available in a nasal spray. Family members have reported being unable to successfully use the available devices in emergency situations.

Evzio is injected into the muscle or under the skin. When it’s activated, it delivers audio messages to family members or caregivers about use, similar to defibrillators used to revive heart attack patients.

Linda Wohlen, 67, who lives near Brockton, Mass., used a traditional naloxone kit to revive her son, Steven, when he overdosed on her front lawn nearly four years ago. An easy, accessible device would be a godsend to families living with addicts.

"I think it's fabulous," she said. "Believe me, anything that saves lives and buys time, I'm all for it."