FDA-Approved Painkiller Zohydro Concerns Critics

By Rita Rubin
WebMD Health News

Reviewed by Michael W. Smith, MD

Feb. 27, 2014 -- A new narcotic painkiller is due to come on the market in March, and critics want the FDA to reverse its approval of the drug, Zohydro ER. They claim it could become the next OxyContin, another opioid that's become a popular drug of abuse.

Critics of the FDA's ruling include attorneys general from 28 states and FED UP!, a union of consumer groups, addiction treatment providers, drug and alcohol prevention programs, and other interested groups. They have petitioned FDA Commissioner Margaret Hamburg, MD, to prevent Zohydro from coming on the market. The FDA approved the drug even though its advisory committee voted 12 to 2 against approval.

"I firmly believe that the benefits of this product outweigh its risks," the FDA's Bob Rappaport, MD, wrote in the summary review explaining why he approved Zohydro last October. Rappaport is director of the FDA's Division of Anesthesia, Analgesia, and Addiction Products. "Many patients in the U.S. suffer from untreated or poorly treated chronic pain. Further limiting access to potential treatments is not the answer when new treatments are critically needed."

Opioids are a man-made type of narcotic pain medication. They subdue the central nervous system, ease pain, and induce sleep. They can have serious side effects if not used properly.

Here are some commonly asked questions about Zohydro, made by Zogenix, a San Diego company.

Q. Why do people want the FDA to reverse its approval of Zohydro?

A. Zohydro is too easy to abuse, critics say. It is the only approved extended-release product that contains the man-made opioid hydrocodone. It will be available in doses as high as 50 milligrams per pill -- five times the amount in immediate-release hydrocodone pills. Even though it is meant to release hydrocodone slowly over 12 hours, the pill could be tampered with to release a large dose all at once, says Andrew Kolodny, MD, co-founder of the group Physicians for Responsible Opioid Prescribing.

Two members of the FDA's controlled substance staff warned about the potential for abuse in materials presented to the advisory committee. "If approved and marketed, Zohydro ER will be abused, possibly at a rate greater than that of currently available hydrocodone combination products," wrote medical officer Lori Love, MD, PhD, and pharmacologist James Tolliver, PhD.

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.


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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.

Physical therapy and cognitive behavioral therapy can help relieve non-cancer chronic pain, Kolodny says. "You can take Tylenol (acetaminophen) and Advil (ibuprofen) and get pretty good pain relief." On very bad days, people could take a Vicodin, Kolodny says. "And the opioid works, because they're not building up tolerance."

Q. Is it unusual for the FDA to go against the recommendation of one of its advisory committees?

A. The agency does sometimes approve a drug that an advisory committee rejected or turns down a drug that an advisory committee endorsed, says Michael Carome, MD. He is director of the Public Citizen health research group, which is among the organizations asking the FDA to reverse its approval of Zohydro.

"In general, the more lopsided the vote, the less likely FDA will go against the recommendation of its advisory committee, but it does on occasion happen," Carome says.

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SOURCES: Jason Jerry, MD, addiction specialist, Cleveland Clinic. Andrew Kolodny, MD, co-founder, Physicians for Responsible Opioid Prescribing; medical director, Phoenix House. Julie Normart, spokeswoman, Zogenix. Michael Carome, MD, director, Public Citizen health research group. Webster's New World Medical Dictionary. FDA Center for Drug Evaluation & Research: "Summary of Minutes: Dec. 7, 2012," "FDA Background Material for Zohydro ER." FDA: "OxyContin: Questions and Answers." Maryland Attorney General: " AG Gansler Urges FDA to Reconsider Zohydro ER Decision." Fed UP!: Letter to Margaret Hamburg.

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