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FDA Approves Anti-Opioid Overdose Device

A hand-held injector that delivers spoken instructions, Evzio will allow people with no medical knowledge to deliver a life-saving dose of naloxone.

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By McCarton Ackerman

04/07/14

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The Food and Drug Administration has taken a major step in helping to curb the epidemic of opioid drug deaths by approving a new device that will allow family members or caregivers to administer medication to combat an overdose.

The new product, called Evzio, is a hand-held automatic injector that quickly delivers a dose of naloxone, which has long been used as an antidote for opioid overdoses from drugs such as heroin, Vicodin, and Oxycontin. The injector gives spoken instructions to the user when activated and is small enough to carry in one's pocket.

The step-by-step instructions make it possible for the first time to allow people with no medical knowledge to inject the drug into a person’s muscle or under the skin. “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,” said FDA Commissioner Margaret A. Hamburg. “[Evzio is] an extremely important innovation that will save lives.”

However, family members and caregivers will need to get a prescription for the drug ahead of time. A price for the device has not yet been determined, but FDA officials said they are committed to making sure opioid users have access to it “regardless of their ability to pay.” Some medical experts have expressed concern that Evzio could create a false sense of security among opioid addicts, but most believe the benefits greatly outweigh any potential harm.

“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,” said Eric Edwards, chief medical officer of Kaleo, the maker of Evzio. “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.”

Despite the FDA’s approval of the drug, the agency has generally been criticized for not doing more to combat opioid addiction. Last October, the FDA approved the controversial painkiller Zohydro, despite their own advisory committee voting against it. U.S. senators Joe Manchino (D-WV) and David Vitter (R-LA) have since launched a bribery investigation after an FDA official allegedly accepted money from pharmaceutical companies in order to obtain a seat on an FDA advisory panel meeting; a spokesman for the FDA has denied the allegations.

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