Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug 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, which is characterized by decreased breathing or heart rates or loss of consciousness.
Drug overdose deaths, driven largely by prescription drug overdose deaths, are the leading cause of injury death in the U.S., surpassing motor vehicle crashes. In 2013, the CDC reported the number of drug overdose deaths had increased steadily for more than a decade.
Naloxone rapidly reverses the effects of opioid overdose, for which it is the standard treatment. However, existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in EDs and ambulances.
“Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the United States,” 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 news release.
“Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a healthcare setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations.”
Evzio is injected into the muscle or subcutaneously. Once turned on, the device provides verbal instruction to the user describing how to deliver the medication, similar to automated defibrillators.
Warnings
Family members or caregivers should become familiar with all instructions for use before administering to individuals known or suspected to have had an opioid overdose. Family members or caregivers also 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.
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 one pharmacokinetic study of 30 patients, a single Evzio injection provided equivalent naloxone compared to 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, uncontrollable trembling, seizures and cardiac arrest.
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.
Evzio is being approved ahead of the product’s prescription drug user fee goal date of June 20, the date the agency originally scheduled to complete review of the drug application.
Family members or caregivers should become familiar with all instructions for use before administering to individuals known or suspected to have had an opioid overdose. Family members or caregivers also 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.
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 one pharmacokinetic study of 30 patients, a single Evzio injection provided equivalent naloxone compared to 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, uncontrollable trembling, seizures and cardiac arrest.
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.
Evzio is being approved ahead of the product’s prescription drug user fee goal date of June 20, the date the agency originally scheduled to complete review of the drug application.
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