FDA approves device to combat opioid drug overdose

The U.S. Food and Drug Administration approved a device designed to combat opioid drug overdose Thursday.

The treatment, Evzio, delivers a single dose of the generic drug, naloxone, the standard treatment for an overdose. Family members or caregivers can operate the pocket-sized device.

"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," Bob Rappaport, director of the FDA's division of anesthesia, analgesia and addiction products, 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."

Drug overdose, mainly from prescription drugs, is the leading cause of death by injury in the United States, the agency said. Opioids specifically are to blame for three out of four prescription drug overdoses, according to the Centers for Disease Control and Prevention, and are more fatal than cocaine and heroin overdoses combined.

"Until now, most people had to rely on emergency medical care to get access to an opioid reversal agent," Allen Burton, an anesthesiologist and pain specialist at Houston Pain Centers, said in a statement released by Kaleo, the maker of Evzio. "Having naloxone available for use by caregivers as soon as signs of overdose are observed means an earlier intervention and better chance of survival."

The FDA advises users that are not healthcare professionals acquaint themselves with the device, even though it offers verbal instructions. Evzio should not be considered an alternative to medical care, however. Opioid overdose symptoms are serious, and include nausea, vomiting, sweating, uncontrollable trembling and increased heart rate and blood pressure.

This approval follows the FDA's release of a new opioid drug, Zohydro, the first prescription narcotic comprised of a pure dose of the painkiller component hydrocodone.

"The FDA approval of EVZIO furthers our mission to make life-saving products that put patients first," said Spencer Williamson, CEO of Kaleo.