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FDA Approves Hand-Held Auto-Injector to Reverse Opioid Overdose

First naloxone treatment designed to be given by family members or caregivers

The FDA has given the green light to a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose.

Evzio (naloxone hydrochloride injection, Kaléo, Inc.) delivers a single dose of naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet. It is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing, decreased heart rate, or loss of consciousness.

Drug overdose deaths, driven largely by fatal prescription drug overdoses, are the leading cause of injury death in the U.S., surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported that the number of drug overdose deaths had steadily increased for more than a decade.

Naloxone is a medication that 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 injected either intramuscularly or subcutaneously. Once turned on, the device provides verbal instruction to the user describing how to deliver the medication, similar to automated defibrillators.

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.

In a pharmacokinetic study involving 30 patients, a single Evzio injection provided equivalent naloxone compared with a single dose of naloxone injection using a standard syringe. The use of Evzio in patients who are opioid dependent may result in severe opioid withdrawal. Abrupt reversal of opioid depression may result in nausea, vomiting, sweating, tachycardia, increased blood pressure, tremulousness, seizures, and cardiac arrest.

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

Evzio was approved ahead of the product’s prescription drug user fee goal date of June 20, 2014.

Source: FDA; April 3, 2014.

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