The U.S. Food and Drug Administration (FDA) has approved the first naloxone treatment specifically designed to be given by family members or caregivers to treat a person with opioid overdose.
Drug overdose deaths, largely from prescription drug overdose, are now the leading cause of injury death in the United States — surpassing motor vehicle accidents. The standard treatment for reversing the effects of opioid overdose is to administer naloxone. However, to date, naloxone could only be given via syringe by trained medical personnel.
EvzioTM (Kaléo Inc, Richmond, Vancouver) is a prescription treatment that delivers a single dose of naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet. EvzioTM can be used by trained non-medical individuals to inject naloxone into the muscle (intramuscularly) or under the skin (subcutaneously). It is intended for the emergency treatment of known or suspected opioid overdose, and is not a substitute for immediate medical care.
A pharmacokinetic study of 30 patients proved a single injection using EvzioTM to be equivalent to a single dose of naloxone using a standard syringe. Naloxone may not remain active as long as opioids, and so repeat doses may be needed. The use of EvzioTM in patients who are opioid dependent may result in severe opioid withdrawal.
The FDA reviewed EvzioTM under its priority review programme, which allows an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists or drugs that offer significantly greater improvement than marketed products.
Bob Rappaport of the FDA’s Center for Drug Evaluation and Research commented “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. EvzioTM is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a healthcare setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations.”