Credit: Reuters/Jason Reed
A view shows the U.S. Food and Drug Administration (FDA) logo at the lobby of its headquarters in Silver Spring, Maryland August 14, 2012.
Drug overdose is the leading cause of death by injury in the United States - surpassing motor vehicle crashes, the regulator said in a statement on Thursday.
The treatment, Evzio, includes an auto-injector that delivers a single dose of the generic drug, naloxone, a standard treatment for overdose. The device can be carried in a pocket or stored in a medicine cabinet. ( http://ift.tt/PqaS97)
It is intended for use by family members or caregivers to treat a person known or suspected to have an opioid overdose.
Once turned on, the device offers verbal instruction to the user describing how to deliver the medication.
Nearly three out of four prescription drug overdoses are caused by painkillers known as opioids that include such drugs as oxycodone, hydrocodone, fentanyl, methadone and codeine, according to the Centers for Disease Control and Prevention, and since 2003 have caused more overdose deaths than cocaine and heroin combined.
Existing forms of naloxone require administration via a syringe and are most commonly used by trained medical personnel.
The drug-device combination, manufactured by privately held kaléo Inc, received approval ahead of its scheduled review date of June 20.
(Reporting by Natalie Grover in Bangalore; Editing by Don Sebastian)
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