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    Critics Oppose FDA Approval of Painkiller Zohydro


    Zogenix is “currently evaluating two different technologies to ensure we develop the most effective formulation to minimize misuse and abuse,” says company spokeswoman Julie Normart. The company is also taking other actions to lower the risk of abuse, according to a statement supplied by Normart. These include locking pill bottle caps and an external “safe-use board” made up of experts in abuse, misuse, and diversion.

    Jason Jerry, MD, an addiction specialist at the Cleveland Clinic, questions why Zogenix doesn’t wait to introduce Zohydro until they develop a version of it that's harder to abuse. “I’m not sure why there’s this great rush to get this to market,” Jerry says.

    Q. What is Zohydro’s selling point?

    A. Zohydro is the first medication that contains only hydrocodone, as opposed to hydrocodone plus acetaminophen (marketed as Lortab and Vicodin) or hydrocodone plus ibuprofen (Vicoprofen). Zogenix says acetaminophen overdose is a leading cause of sudden liver failure in the U.S. Nearly two-thirds of those overdoses are attributed to medications that include hydrocodone and acetaminophen, Zogenix says.

    But patients with liver failure have multiple acetaminophen-free opioids to choose from, Kolodny says. And, Jerry says, “acetaminophen acts as a deterrent to addicts. They know it’s toxic to the liver.”

    Q. Who is Zohydro supposed to treat?

    A. According to the FDA-approved labeling, Zohydro is "for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternate treatment options are inadequate.” The manufacturer can’t market it for other uses, but doctors are free to prescribe it to any patient they deem appropriate.

    Q. Are there other treatments for people with chronic pain?

    A. With a variety of other opioids on the market, Kolodny says, no one needs Zohydro. He and Jerry also say there is little research into whether opioids relieve non-cancer pain, such as that from osteoarthritis, beyond 3 months or so.

    Opioids are “lousy drugs for non-cancer chronic pain,” says Kolodny, who also is medical director of Phoenix House, a nonprofit organization that provides alcohol and drug abuse treatment and prevention services in 11 states.

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