FDA Okays Handheld Autoinjector for Opioid Overdose

Caroline Cassels

April 03, 2014

The US Food and Drug Administration (FDA) has approved a handheld device designed for use by family members or caregivers to deliver a single dose of naloxone to reverse suspected opioid overdose.

The device, known as Evzio (naloxone hydrochloride injection, Kaléo, Inc) can be carried in a pocket or stored in a medicine cabinet and is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness.

"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 healthcare setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations," he added.

Drug overdose, driven largely by prescription drug overdose deaths, is now the leading cause of injury death in the United States.

Naloxone rapidly reverses the effects of opioid overdose and is the standard treatment for overdose. However, existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.

Evzio is delivered via intramuscular injection or subcutaneously. Once turned on, the device provides verbal instruction to the user describing how to deliver the medication, similar to automated defibrillators.

According to the manufacturer, because naloxone may not work as long as opioids, repeat doses may be needed. Evzio is not a substitute for immediate medical care, and the person administering Evzio should seek further, immediate medical attention on the patient's behalf.

Use of Evzio in opioid-dependent patients may result in severe opioid withdrawal. Abrupt reversal of opioid depression may result in nausea, vomiting, sweating, accelerated heart rate (tachycardia), increased blood pressure, uncontrollable trembling (tremulousness), seizures, and cardiac arrest.

The FDA reviewed Evzio under the agency's priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared with marketed products.

The product was granted a fast-track designation, a process designed to facilitate the development and to expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Evzio is being approved ahead of the product's prescription drug user fee goal date of June 20, 2014, the date the agency was originally scheduled to complete review of the drug application.


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