FDA Approves Drug That Reverses Heroin Overdoses

After steadily increasing for more than a decade, drug overdose deaths, driven largely by pain prescription drugs like oxicodone, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes.

In response, the U.S. Food and Drug Administration yesterday approved a prescription treatment that can be used by family members or caregivers in an emergency to aid a person who may be overdosing on heroin, morphine or other opiates. The injection treatment rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet.

Naloxone is the standard treatment medication that rapidly reverses the effects of opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness. However, existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.

“Overdose and death resulting from misuse and abuse of both prescription and illicit heroin has become a major public health concern in the United States,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia, and Addiction Products for the FDA. “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.”

Once activated, the device provides verbal instruction to the user describing how to deliver the medication, similar to automated defibrillators.

Because naloxone may not work as long as opioids, repeat doses may be needed and the person administering Evzio should seek further, immediate medical attention on the patient’s behalf.

The FDA reviewed Evzio under the agency’s priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. The product was granted a fast-track designation, a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Evzio’s approval is also the result of efforts by several federal agencies, including the White House’s Office of National Drug Control Policy since 2012.

(Source: FDA)