Jim Morrison should have had this one. But seriously, drug addiction is a debilitating, dangerous, and often fatal condition. According to a 2013 Centers for Disease Control and Prevention report, opioid overdose deaths have been steadily increasing for over a decade, and now account for 16,000 deaths per year in the United States. Some communities have implemented harm reduction programs, which include training of neighbors to recognize patients who’ve overdosed and to deliver a manually-injected or nasally-sprayed antidote of naloxone, but these methods can be cumbersome, slow, and prone to error.
In light of this increasing need, the FDA has now approved an auto-injecting syringe for opioid overdose. The Evzio (naloxone hydrochloride injection) from Kaleo, a company out of Richmond, Virginia, is a device for administering a single dose of naloxone to be delivered easily and rapidly to an opioid depressant overdose patient. It can be powered on to activate a voice that reads the instructions, similar to AEDs, or the instructions can be found written on the device itself. Like the Epipen, the Evzio works by punching the tip of the syringe directly onto the thigh’s muscles and even through clothing. This releases the needle and delivers the medication. In a pharmacokinetics study of 30 patients, the naloxone dose delivered by an Evzio injection was equivalent to that of a standard syringe. Each kit comes with two doses and has a shelf-life of two years. The website recommends delivery of a single dose every 2 to 3 minutes until emergency medical care arrives, as the antidote wears off quickly.
“This product is the first auto-injector designed to rapidly reverse the overdose of either prescription or illicit opioids,” said FDA Commissioner Margaret A. Hamburg in a statement on prescription opioid abuse. “While the larger goal is to reduce the need for products like these by preventing opioid addiction and abuse, they are extremely important innovations that will help to save lives.”
Link: FDA Commissioner Margaret A. Hamburg’s statement on the announcement…
Press release: FDA approves new hand-held auto-injector to reverse opioid overdose…
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