The FDA has approved the first portable emergency naloxone hydrochloride injection device (Evzio) intended for use by family and caregivers to reverse opioid overdose.

The automatic injector device gives verbal instructions to the user, similar to automated defibrillators, and is small enough to carry in a pocket.

“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,” said Bob Rappaport, MD, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research. “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.”

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Drug overdose, largely attributable to prescription drugs, recently surpassed motor vehicle crashes as the leading cause of injury deaths in the United States, according to the agency. 

Family members and caregivers of patients taking opioid drugs should become familiar with all instructions for using Evzio before administering emergency naloxone hydrochloride injections to patients in need and should practice with the included trainer device, according to the FDA.

The approval was based on findings from a pharmokinetic study involving 30 patients in which a single Evzio injection provided an equivalent dosage of naloxone compared with a single dose delivered using a standard syringe.

Patients on whom the device is used may develop symptoms of severe opioid withdrawal, including nausea, vomiting, sweating, tachycardia, increased blood pressure, tremulousness, seizures and cardiac arrest, the FDA warned. Therefore, caregivers administering Evzio should seek further, immediate medical attention on behalf of the patient.

Evzio was approved under the FDA’s fast-track designation, a process designed to expedite review of drugs and devices to fill unmet medical needs. The device is manufactured by kaléo, Inc., of Richmond, Va.