FDA Approves EVZIO For Opioid Overdose
The U.S. Food and Drug Administration (FDA) has approved the first and currently the only naloxone product intended for emergency treatment of opioid overdose. Kaleo’s EVZIO received priority review and approval under the FDA’s Fast Track program.
Spencer Williamson, CEO of Kaléo, said “The FDA approval of EVZIO furthers our mission to make lifesaving products that put patients first. We are thankful to the patients and caregivers whose input guided the development process and resulted in an intuitive and important product we’re proud to bring to market.”
EVZIO is a pre-filled, single-use auto-injector designed to temporarily block opioid effect. The drug can be administered by family members or caregivers to reverse life-threatening respiratory depression and help a recipient to breathe more freely. The drug may be administered repeatedly once its effects wear off and opioid overdose systems reappear. Kaleo said that there is no potential for abuse or dependence with naloxone.
FDA Commissioner Margaret Hamburg stated in a press release, “Today’s FDA approval of Evzio (naloxone autoinjector) provides an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose, which is one part of our comprehensive work to support opioid safety.” The Commissioner said the agency will continue to work to reduce the risks of abuse and misuse of prescription opioids, but asserted that it cannot solve the problem alone.
Hamburg called for support from sister agencies, the DEA, and health care organizations among others for a comprehensive and coordinated approach in addressing opioid abuse. “I am confident that this can be accomplished, but we will all need to work together to invest in strategies and responsible approaches that deter or mitigate the effects of abuse while preserving access to pain medicines for the patients that need them the most,” the Commissioner said.
The drug is expected to be available this summer in all major pharmacies and via mail order with a healthcare professional’s prescription.