Caregivers Can Now Administer Opioid Overdose Treatment

Drug overdose deaths have now surpassed automobile collisions as the leading cause of accidental death in the U.S., and more than 16,000 Americans die each year from prescription opioid overdose in particular, according to the U.S. Food and Drug Administration.

A new handheld treatment that reverses overdose from either prescription or illicit opioids could help to reduce that number. The FDA approved Evzio (naloxone hydrochloride injection, kaléo, Inc.) on April 3, after reviewing the drug under its priority review program and granting it a fast-track designation. It is the first naloxone treatment specifically designed to be given by family members or caregivers.

Minimizing Opioid Risks: Two Viewpoints
Opioids the New Drug of Choice for Children

“[The] FDA approval of Evzio provides an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose, which is one part of our comprehensive work to support opioid safety,” FDA Commissioner Margaret A. Hamburg said in a statement released on April 3. “While the larger goal is to reduce the need for products like these by preventing opioid addiction and abuse, they are extremely important innovations that will help to save lives.”

Naloxone has long been considered the standard treatment for overdose; however, it must be administered via syringe and is most commonly used by trained medical personnel in emergency departments and ambulances. Evzio will enable family members or caregivers to immediately administer the drug in emergency situations where opioid overdose is known or suspected.

The handheld auto-injector, which can fit in a pocket or be stored in a medicine cabinet, rapidly delivers a single dose of the drug. It works by temporarily blocking the effect of an opioid, potentially reversing life-threatening respiratory depression and allowing the recipient to breathe more regularly.

Evzio is injected into the muscle or under the skin, and once the device is turned on, it provides the user with verbal instructions describing how to deliver the medication. This prescription treatment is not intended as a substitute for immediate medical care—but rather a potentially life-saving intervention that can be used while help is on the way.

The person administering Evzio should seek further, immediate medical attention for the patient. Because naloxone may not work as long as opioids, repeat doses may be needed, and its use in patients who are opioid dependent may result in severe opioid withdrawal.

“The FDA will continue to work to reduce the risks of abuse and misuse of prescription opioids, but we cannot solve this complex problem alone,” Hamburg said. “I am confident that this can be accomplished, but we will all need to work together to invest in strategies and responsible approaches that deter or mitigate the effects of abuse while preserving access to pain medicines for the patients that need them the most.”

Evizio is expected to be available this summer.

Colleen Mullarkey