The US Food and Drug Administration (FDA) has provided fast-track approval for the nonclinician use of Evzio, an easy-to-use autoinjectable device with a single dose of naloxone for the reversal of opioid overdose, according to a news article published in JAMA.
As of 2014, Evzio was the first naloxone product to be cleared by the FDA for use outside a clinical setting. Physicians can prescribe this device, which contains a single 2-mg dose of naloxone, to individuals taking prescription opioids or to their household members.
Naloxone has been heavily used in emergency departments in recent years for people experiencing an opioid overdose, and it is also used to reverse the effects of anesthesia. Naloxone acts by competitively binding to opioid receptors and is effective in reversing respiratory depression, thus preventing death.
Because many opioid overdoses occur outside of clinical settings, officials have attempted to ease access to fast-acting naloxone devices for nonclinicians to administer emergency treatment. The Substance Abuse and Mental Health Services Administration advises physicians who prescribe opioids to recommend naloxone to prevent overdose by patients or others in their households.
Evzio, the first product of its kind to be approved by the FDA, comes with step-by-step instructions that appear once the device is activated.
Kuehn BM. Easy-to-use overdose antidote earns fast-track approval. JAMA. 2014;311:1600.