Va. firm wins FDA approval for overdose treatment

RICHMOND, Va. (AP) — A Richmond-based company has received federal approval for a drug treatment that reverses the effects of pain medicine or heroin overdose.

According to the Richmond Times-Dispatch (http://bit.ly/1lFCyom ), the U.S. Food and Drug Administration on Thursday granted fast-track approval for Evzio, an emergency injector developed by the pharmaceutical development company Kaleo. The product is the size and shape of a credit card with the thickness of a small cellphone. It can be used by family members or caregivers to treat a person known or suspected to have overdosed on opioids, pain medications used to treat acute and chronic medical conditions.

Eric Edwards, the company's chief medical officer and vice president, said the product could be available by prescription as early as this summer.

"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 Dr. Bob Rappaport with the FDA's Center for Drug Evaluation and Research. "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."

Kaleo was founded in 2004 by brothers Eric and Evan Edwards to develop medical products to treat sudden, life-threatening conditions. The company received FDA approval in 2012 for its first product, an auto-injector device called Auvi-Q that can deliver life-saving medication to someone suffering from a severe allergic reaction.

Evzio operates in a similar way to Auvi-Q, but delivers a different drug. Naloxone has been used for four decades by medical professionals to counter the effects of opioid overdoses.

Kaléo reformulated the drug so that it can be delivered using the auto-injector in non-medical settings. The existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency rooms and ambulances.

Evzio is automatically injected into the muscle or under the skin, usually in the thigh, and it can be administered through clothing.

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Information from: Richmond Times-Dispatch, http://www.timesdispatch.com

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