Ralph B. DavisManaging Edtior
December 11, 2012
WASHINGTON, D.C. — Officials concerned about a proposed new painkiller said to be 10 times more powerful than Vicodin were granted a ray of hope Friday evening, when a government panel of pain experts voted overwhelmingly to recommend the drug be rejected.
California drug maker Zogenix announced its intention last January to begin selling Zohydro next year, making it the first pure hydrocodone tablet on the market. Other hydrocodone medications, such as Vicodin or Lortab, are usually mixed with other pain suppressants, such as acetaminophen or aspirin.
When the drug was announced, it was roundly criticized in government, law enforcement and health circles as holding too much potential for abuse.
In January, Floyd County Coroner Greg Nelson said he did not think there was a need for such a drug, considering the number of overdose deaths caused by hydrocodone he sees in his line of work.
“The hydrocodone we have now is cut, and we have plenty of ODs with that,” Nelson said. “I think this will only make things worse.”
The FDA panel apparently agreed, citing concerns about the potential for abuse in voting not to approve the new drug.
In a background document about the drug, prepared in advance of Friday’s vote, officials expressed concern about the drug.
“If approved and marketed, Zohydro ER will be abused, possibly at a rate greater than that of currently available hydrocodone combination products,” the authors noted in the document.
The document also noted that there were five deaths during testing of the drug on 1,512 people. Of the five deaths, four were not tied directly to Zohydro. The fifth death, however, resulted after the patient “hoarded Zohydro ER capsules and then opened and ingested all the medication” at the conclusion of testing.
The panel voted 11-2, with one abstention, against approving the drug. The vote is not binding on the Food and Drug Administration, which has ultimate power to reject or approve the drug, but is seen as a good indication of what action the FDA is likely to take.