FDA announced the approval of Kaléo's Evzio (naloxone hydrochloride injection), 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 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.
The drug is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness.
According to FDA, drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States, surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported 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 into the muscle or under the skin. 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 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.
"For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain. I firmly believe that these goals are compatible, and that actions to address one should not be at the expense of the other," said FDA Commissioner Margaret A. Hamburg in a separate statement released with the approval announcement.
"Today's 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. Reflecting the FD'’s commitment to encouraging important new therapies, the FD'’s review of Evzio was granted priority status, and the application was reviewed by the FDA in just 15 weeks," she said.
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. In addition, Evzio was approved ahead of the product's prescription drug user fee goal date of June 20, 2014, the date the agency was originally scheduled to complete review of the drug application.