Earlier last week, the FDA approved Evzio (naloxone hydrochloride injection), which can be administered to patients suffering from an opioid overdose via a hand-held auto injector. The treatment is the first approved by the FDA for use by family members in treating patients who are believed to have undergone an opioid overdose. The FDA's approval of the new, auto-injector treatment will allow patients to potentially get quicker treatment. Drug overdose is now the U.S.’ leading cause of injury death.
Bob Rappaport, director of the Division of Anesthesia, Analgesia, and Addition Products at the FDA, said that the approval of Evzio could save lives. “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,” said Rappaport. “Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations.” Currently, most naloxone treatments must be done by syringe by emergency medical personnel. The auto-injector is relatively small and can be easily transported or stored.
The FDA continued by stating that Evzio is not a substitute for medical care. Family members or care givers administering treatment via the hand-held device should still call emergency medical personnel immediately if they believe someone is suffering from an opioid overdose. Repeat doses might be necessary, as naloxone doesn't work as long as some opioids. In one particular study carried out on 30 patients, a single Evzio injection provided equivalent naloxone compared to a single dose of noxolene injection administered via standard syringe.
Evzio was reviewed by the FDA under its priority review program and granted fast-track designation. Evzio is being approved ahead of the product’s prescription drug user fee goal date of June 20, 2014.