FDA approves naloxone auto-injector device Evzio

April 6, 2014

Virginia-based Kaléo Pharma has received FDA approval for a naloxone auto-injector. Evzio can be administered by family members or caregivers to rapidly deliver naloxone to reverse an opioid overdose. Naloxone has long been used as an antidote for opioid overdoses and is often distributed to users of opioid drugs through needle exchanges and other locations in several countries worldwide. The FDA fast-tracked the approval of Evzio under its expedited priority review process which is used for drugs that treat serious medical conditions or fill an unmet medical need.

FDA approves device to combat opioid drug overdose
The Washington Post - April 3, 2014

In a move aimed at stemming the tide of deaths caused by the nation's prescription drug epidemic, the Food and Drug Administration on Thursday approved a new device that would allow family members or caregivers to administer emergency medication to combat an overdose.

The product, Evzio, rapidly delivers a dose of naloxone, a long-used antidote to overdoses of a powerful class of painkillers known as opioids, which include legal drugs such as Vicodin and OxyContin, as well as illicit drugs such as heroin. The treatment would be administered through a hand-held automatic injector that, when activated, gives spoken instructions to the user and is small enough to carry in a pocket.

Federal officials fast-tracked the approval of Evzio — the FDA reviewed its application in less than four months — saying it could play a critically important role in preventing some of the estimated 16,000 annual deaths attributed to prescription drug overdoses, a problem that has grown steadily worse over the past decade.

Opioid overdoses are marked by slowed breathing, extreme fatigue and changes in heart rate. Because victims tend to lose consciousness and fall ill quickly, allowing nearby family members or caretakers to administer naloxone rather than waiting on paramedics or doctors could mean the difference between life and death.

"For years, the lack of a lay-friendly delivery system has made it difficult to make naloxone broadly available to the public and to foster its use in non-medical settings, where it is often most urgently needed," FDA Commissioner Margaret A. Hamburg told reporters Thursday, calling Evzio "an extremely important innovation that will save lives."

Regulators warned that Evzio should not be considered a substitute for medical care, that it works only temporarily to reverse overdose effects, and that it can trigger opioid withdrawal symptoms, including nausea, vomiting, sweating, uncontrollable trembling, and increased heart rate and blood pressure.

Still, the approval of Evzio will for the first time allow people with no medical knowledge to inject the drug into a patient's muscle or under the skin during an emergency by walking them through each step verbally, much like an automated defibrillator.

Family members or caregivers will need to get a prescription for the product ahead of time. But doing so would allow them to have a portable dose of naloxone in an easy-to-use injector about the size of a credit card and the thickness of a cellphone.

"This is an important milestone for the millions of patients taking opioids who are trying to balance pain management with the safe use of opioids, as well as those who are struggling with abuse," Eric Edwards, chief medical officer of Kaleo, the maker of Evzio, told reporters Thursday. "What we've realized is that opioid overdoses do not discriminate...We want to make sure this product is made available to all who could benefit from it."

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