FDA Approval Puts Opioid Overdose Reversal in Patients' Hands

The FDA has approved Evzio (naloxone HCl injection; Kaléo, Inc.) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Evzio is the first hand-held auto-injector that quickly delivers a single dose of naloxone 0.4mg. It is available to patients, family members or caregivers via prescription, and can be carried in a pocket or stored in a cabinet. Naloxone is a narcotic antagonist that rapidly reverses the effects of opioid overdose and is the standard treatment.

Evzio is given as an intramuscular or subcutaneous injection. Once the device is turned on, verbal and visual cues are provided that describe how to administer the drug, similar to automated defibrillators. Evzio is not intended to be a substitute for immediate medical care, and the administrator should seek immediate medical attention.

A study of 30 patients showed that a single injection of Evzio provided equivalent naloxone compared to a single injection given via a standard syringe. Evzio was reviewed under the FDA’s priority review program and was also granted a fast track designation.

FDA Approval Puts Opioid Overdose Reversal in Patients’ Hands

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