The U.S. Food and Drug Administration (FDA) has approved EVZIO™ (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. EVZIO is the first and only naloxone auto-injector intended to be available for immediate administration by family members or caregivers for suspected opioid overdose in settings where opioids may be present.
More than 16,000 Americans die each year from prescription opioid overdose. Naloxone, the active ingredient in EVZIO, has been used for more than 40 years for reversal of respiratory depression due to opioid overdose, but has been primarily used by emergency medical services, other medical professionals and in limited naloxone distribution programs. EVZIO is expected to be available this summer to patients and their family members or caregivers through all major pharmacies and via mail order with a healthcare professional’s prescription. EVZIO uses voice and visual cues to assist in guiding a user through the injection process.
The FDA press announcement of approval may be read here.