FDA approves auto-injector for treatment of painkiller overdose
- April 3, 2014
The Food and Drug Administration has approved an auto-injector developed by a Richmond pharmaceutical company for emergency treatment of an overdose involving powerful painkillers.
EVZIO is a pre-filled, single-use auto-injector that works by temporarily blocking the effect of an opioid, potentially reversing life-threatening respiratory problems and allowing the patient to breathe more regularly.
EVZIO was developed by Richmond-based Kaléo (formerly known as Intelliject). It says EVZIO is the first auto-injector with the active ingredient naloxone that is intended to be available for use by family members or caregivers on a patient with a suspected opioid overdose.
Opioids are part of a class of pain medications that affect the body’s perception of pain. They can cause a fatal overdose when the drug amount in the body is too high. An overdose can cause a person’s breathing to severely slow down and even stop.
Naloxone has been used for more than 40 years for treatment of opioid overdose. However, it has been primarily used by medical professionals and in limited distribution programs. EVZIO will be available to patients and their family members or caregivers via prescription.
The new drug application for EVZIO was granted fast-track status and received a priority review by the FDA. Fast-track status accelerates the review and approval of products that fill an unmet medical need.
EVZIO is expected to be available in pharmacies this summer.