FDA Approves Auto-inject Rescue Medication for Opioid Overdose

Evzio (naloxone hydrochloride injection) now can be used at home to prevent accidental overdoses

A 2014 PPM Brief

The Food and Drug Administration (FDA) has approved a hand-held auto-inject rescue medication for opioid overdose that can be used at home.1 Previous products were only available to emergency medical service (EMS) workers or emergency room doctors. The approval of Evzio (naloxone hydrochloride injection) should help stem the rising tide of accidental overdoses from prescription opioid medications and heroin.

In 2010, over 16,000 deaths were linked to overdoses of prescription opioids—that was more than overdoses from heroin and cocaine combined. When used a prescribed, opioids such as OxyContin (oxycodone) and Vicodin (hydrocodone with acetaminophen) can help people with acute and chronic pain conditions.

However, in the past decade, the United States has seen a sharp rise in the number of prescription written for opioids, leading to “an epidemic of opioid abuse and misuse in the US,” noted the Centers for Disease Control and Prevention.

"Whether opioids are used by patients as prescribed by their health care professional or are misused or abused, these drugs have one important thing in common: They can all cause rapid and fatal overdose," noted Dr. Douglas C. Throcknorton in a blog post on the FDA website.2

According to Dr. Throcknorton, the “FDA, along with other organizations, has been working diligently on ways to address this major public health issue. That’s why FDA has approved a drug-device combination product that delivers the medication known as naloxone, which is the standard treatment for a drug overdose.”

How it Works

Evzio is injected into the muscle (intramuscular) or under the skin (subcutaneous). Once turned on, the device provides verbal instruction to the user describing how to deliver the medication, similar to automated defibrillators.

Evzio delivers a single dose of the naloxone, which will rapidly reverse the effects of opioid overdose. One should suspect an overdose if the person has shallow breathing, slow heart rate, or has lost consciousness.  

Family members or caregivers of patients on opioid therapy should become familiar with the steps for using Evzio and practice with the trainer device, which is included along with the delivery device, before it is needed, noted the FDA.

Once used, the person administering Evzio should seek further, immediate medical attention on the patient’s behalf. Since naloxone reverses the effects of opioids, it can also cause the patient to experience immediate withdrawal systems. “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,” noted the FDA. These symptoms are best treated by medical professionals.

Study Results

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

Evzio is manufactured for kaléo, Inc, of Richmond, Va.

Updated on: 03/05/19