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news.Kaleo (formerly Intelliject) has announced that the US 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.
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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.
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 will be available to patients and their family members or caregivers via a healthcare professional’s prescription. EVZIO should be administered as quickly as possible when an opioid overdose is suspected because prolonged respiratory depression may result in damage to the central nervous system or death.
Because people experiencing an opioid overdose generally lose consciousness, in most cases, family members or caregivers will likely be the ones who administer EVZIO. EVZIO uses voice and visual cues to assist in guiding a user through the injection process.1
Kaleo chief medical officer Dr Eric Edwards noted the company was founded on the idea that patients are true experts on how their conditions impact their lives, and EVZIO was developed with patient and caregiver input throughout to make sure it would be easy to use in stressful opioid emergencies with limited training.
"Immediate availability of EVZIO for family members and caregivers to administer during a suspected opioid overdose has the potential to save many lives," Dr Edwards added.
The new drug application (NDA) for EVZIO was granted Fast Track status and received a priority review by the FDA, which are regulatory pathways to accelerate the review and approval of products that fill an unmet medical need.
EVZIO is expected to be available this summer through all major pharmacies and via mail order with a healthcare professional’s prescription. An assistance program will be available to help patients gain access to EVZIO.