FDA Approves First Auto-injector for Reversal of Opioid Overdose

April 4, 2014
Jackie Syrop

The US Food and Drug Administration approved the first naloxone treatment specifically designed to be given by family members or caregivers to treat a person known or suspected of an opioid overdose.

The US Food and Drug Administration approved the first naloxone treatment specifically designed to be given by family members or caregivers to treat a person known or suspected of an opioid overdose.

Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone through a new handheld auto-injector that can be carried in a pocket or stored in a medicine cabinet. Naloxone rapidly reverses the effects of opioid overdose. Existing naloxone drugs require administration via syringe and are not easily used by nonmedical personnel. In a study of 30 patients, a single injection of Evzio proved equivalent to a single naloxone injection delivered by a standard syringe.

“Making this product available could save lives by facilitating earlier use of the drug in emergency situations,” Bob Rappaport, MD, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

Evzio is injected into the muscle or under the skin. Once turned on, the device provides verbal instruction to the user about how to deliver the medication.

Because the effect of naloxone may not work as long as opioids, repeat doses may be needed. The medication is not a substitute for medical care, and the person administering Evzio should seek further, immediate medical attention on the patient’s behalf, according to the FDA.

According to the FDA, potential side effects of abrupt reversal of opioid depression include nausea, vomiting, sweating, accelerated heart rate, increased blood pressure, uncontrollable trembling, seizures, and cardiac arrest.

Evzio is a product of kaléo, Inc., based in Richmond, VA.