FDA Approves Kaleo's Evzio For Opioid Overdose
By Cyndi Root
Kaléo, formerly Intelliject, announced via press release that the Food and Drug Administration (FDA) has approved Evzio (naloxone hydrochloride). Packaged in an auto-injector, the drug is for emergency administration in the event of an opioid overdose. Family members or caregivers who observe respiratory and/or central nervous system depression or suspect an overdose can administer the drug immediately and improve the person’s chance of survival. Eric Edwards, CMO of Kaléo said, “Kaléo 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.”
Opioid Overdose
In 2010, almost 40,000 people overdosed on pharmaceuticals and opioids according to a Centers for Disease Control (CDC) report. Bob Rappaport, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research said in a press release, “Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the United States.”
Evzio
Evzio (naloxone hydrochloride) has been used for more than 40 years to reverse opioid overdose. However, medical professionals have traditionally administered it in an emergency room setting. The product (drug and injecting device) assists the administrator with visual and voice cues, along with instructions to give the drug as quickly as possible.
The FDA granted Evzio priority review and Fast Track status because of the serious unmet need that opioid overdose poses. Kaleo expects the drug to be available by summer. People can get a prescription from a physician and fill it at a brick and mortar or online pharmacy. The company will provide an assistance program to help medical professionals, patients, and caregivers learn more.