The auto-injector -- named Evzio -- was specifically designed so a family member or caregiver could administer a single dose of Naloxone to someone suspected of having an overdose. Opioids include heroin, morphine and prescription painkillers.
Existing naloxone drugs require administration via syringe and are most commonly used by healthcare personnel.
The FDA added that anyone using Evzio to inject Naloxone should seek further medical help on the patient’s behalf.
“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,” Dr. 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 statement.
“Evzio 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.”