FDA staff says Zogenix painkiller has abuse risks

Wed Dec 5, 2012 9:34am EST

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(Reuters) - Drug reviewers said a painkiller developed by Zogenix Inc could possibly be abused more than currently available hydrocodone combination products.

Zogenix's painkiller Zohydro is a single-entity product containing hydrocodone -- a narcotic painkiller. Hydrocodone and oxycodone are often-abused drugs.

Combination hydrocodone drugs usually also contain acetaminophen, the active ingredient in common pain products such as Tylenol.

However, since an overdose of acetaminophen can cause liver damage, especially in patients on other acetaminophen medications, there is a requirement for painkillers without acetaminophen.

The reviewers said the expected higher levels of abuse with Zohydro were based on what has been observed for oxycodone products, according to briefing documents released by the U.S. Food and Drug Administration on Wednesday. (link.reuters.com/hux44t)

"The abuse ratio for oxycodone combination products was 24 emergency department visits per million tablets dispensed, compared with 85 visits for oxycodone single-entity ER products," the FDA reviewers said in the documents.

An independent panel of experts will advise the FDA and vote on the drug's safety, efficacy and approval on Friday.

Zogenix shares were down 6 percent at $2.39 in early trade on Wednesday on the Nasdaq.

(Reporting by Esha Dey in Bangalore; Editing by Roshni Menon)

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Comments (1)
CalGal wrote:
Could we please, for once, consider the needs of pain patients for whom Zohydro was created, instead of worrying about what the junkies are going to do?
Many lives have been already made more difficult with the Vicodin reformulation. Patients now get Norco, which is NOT as effective. It seems that the addicts are running the show while suffering patients are thrown under the bus again and again.

Dec 05, 2012 2:35pm EST  --  Report as abuse
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