By Rita Rubin
WebMD Health News
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.
source : FDA-Approved Painkiller Zohydro Concerns Critics