Evzio is a hand-held auto injector that delivers a single dose of the drug naloxone into the muscle or beneath the skin. The injector can be carried in a pocket or stored in a medicine cabinet and is meant as an emergency treatment for people who have suffered a known or suspected overdose of powerful pain drugs called opioids.
Opioids include prescription narcotic painkillers such as Oxycontin, Vicodin and Percocet -- all of which have shown increasing rates of abuse in recent years.
"Tragically, the most recent data shows that more than 16,000 lives are lost each year due to opioid-related overdoses," FDA Commissioner Margaret Hamburg said in an agency statement. "In fact, drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States -- surpassing motor vehicle crashes."
She called Evzio's "fast-tracked" FDA approval "an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose."
Naloxone rapidly reverses the effects of overdose and is the standard treatment in such cases. However, current naloxone drugs have to be injected with a needle and their use is typically limited to trained medical personnel, the FDA noted.
"Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting," Dr. Bob Rappaport, director of the division of anesthesia, analgesia, and addiction products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
"Making this product available could save lives by facilitating earlier use of the drug in emergency situations," he explained.
When it's turned on, Evzio provides users with verbal instructions on how to deliver the medication. Family members and caregivers should learn all the instructions before they may have to use Evzio and should practice with the trainer device that comes with it, the FDA advised.
According to the FDA, one study involving 30 patients showed a shot of Evzio delivered the equivalent of a single dose of naloxone using a standard syringe. People who receive a shot of Evzio may experience "severe opioid withdrawal," the agency said.
There are dangers with quick withdrawal from "opioid depression," the FDA said, with symptoms such as nausea, vomiting, sweating and accelerated heart rate, and a risk for spikes in blood pressure, seizures and even cardiac arrest.
It also noted that repeat doses may be necessary and that Evzio is not a substitute for immediate medical care.
The U.S. National Institute on Drug Abuse has more about opioids.