FDA approves emergency device to combat opioid drug overdose

Washington - In a move meant to prevent deaths caused by the nation's prescription drug epidemic, the Food and Drug Administration on Thursday approved a new device that would allow family members or caregivers to administer emergency medication to combat an overdose.

The product, Evzio, rapidly delivers a dose of naloxone, a drug that has long been used to reverse the effects caused by an overdose of a powerful class of painkillers known as opioids. The treatment would be administered through a hand-held automatic injector that gives verbal instructions to the user and is small enough to carry in a pocket.

Federal officials fast-tracked approval of Evzio, saying it could play a critically important role in preventing some of the 16,000 deaths per year attributed to painkiller abuse, a problem that has grown steadily worse over the past decade and now eclipses the number of people killed in automobile crashes. Because victims of opioid overdose tend to lose consciousness, allowing nearby family members or caretakers to administer naloxone outside a hospital setting could mean the difference between life and death for some patients.

"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," Bob Rappaport, director of the FDA's division of anesthesia, analgesia and addiction products, said in a statement. "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."

Although the FDA said family members or caregivers should make themselves familiar with Evzio before using it, the device walks users through administering the drug in an emergency situation, much like an automated defibrillator.

The drug is injected into a patient's muscle or under the skin. It is designed to counteract the symptoms of opioid overdose, including slowed breathing, extreme fatigue and changes in heart rate.

In approving the Evzio, regulators warned that it should not be considered a substitute for medical care, and that the use of the drug can result in severe opioid withdrawal symptoms, including nausea, vomiting, sweating, uncontrollable trembling and increased heart rate and blood pressure.

"Until now, most people had to rely on emergency medical care to get access to an opioid reversal agent," Allen Burton, an anesthesiologist and pain specialist at Houston Pain Centers, said in a statement released by Kaleo, the maker of Evzio. "Having naloxone available for use by caregivers as soon as signs of overdose are observed means an earlier intervention and better chance of survival."

Thursday's approval comes amid continuing criticism of the FDA over the recent release of a new opioid drug, Zohydro. It is the first prescription narcotic comprising a pure dose of hydrocodone, the main ingredient in the painkiller Vicodin.

Before Zohydro, hydrocodone was available only in combinations that included non-addictive pain medications, such as acetaminophen. The FDA agreed with the drug's California manufacturer, Zogenix, that the pure formulation allows for long-term use without the risk of liver damage and would offer a much-needed treatment for chronic pain sufferers.

Meanwhile, critics have warned that such a formulation also makes the drug easier to abuse. In addition, they argue that Zohydro's lack of tamper-resistant features, coupled with its potency - the strongest version includes 10 times the amount of hydrocodone in many Vicodin pills - is a recipe for disaster.

The FDA approved the controversial drug last fall despite an 11-to-2 recommendation to the contrary by its own outside advisory panel. The agency has continued to face pressure to reconsider its decision from law enforcement officials, addiction experts and lawmakers from both parties, though officials have defended its merits as a painkiller.

Last month, the manufacturer of another opioid drug, OxyContin, said it had successfully tested a tamper-resistant form of hydrocodone and plans to seek FDA approval for the drug, which it said would be less prone to abuse because its design makes it hard for users to crush the pill and inject or snort its contents.


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