U.S. FDA chief defends approval of Zogenix's 'unique' pain drug Zohydro

by Reuters
Thursday, 13 March 2014 15:41 GMT

By Susan Heavey

WASHINGTON, March 13 (Reuters) - U.S. Food and Drug Administration Commissioner Margaret Hamburg on Thursday defended the agency's approval of Zogenix Inc's Zohydro, saying the powerful prescription opioid offered a unique option to help treat pain.

Law enforcement officials, doctors and addiction treatment specialists are concerned that Zohydro would set off a wave of addiction similar to problems with the original form of OxyContin.

Hamburg, responding to a query from a U.S. lawmaker, acknowledged the potential for abuse with the medication and the broad problem of opioid painkillers addiction in the United States. But, she said, Zohydro offered a "very important" option for certain patients.

"We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy, recognizing its addiction potential and understanding, of course, the broader context of the serious problem of opioid medication abuse and misuse in this country," Hamburg said at a hearing of the Senate's Health, Education, Labor and Pensions Committee.

After Hamburg's comments, shares of the San Diego, California-based pharmaceutical company rose more than 5 percent before settling up 3.7 percent at $3.64 in late-morning trade on the Nasdaq.

Zohydro is expected to hit the U.S. market this month after the FDA cleared the painkiller in last year, overruling its panel of outside advisers who recommended against approval, citing safety concerns about the potential for abuse.

Attorneys general from scores of U.S. states as well as dozens of groups representing physician and addiction treatment experts have called on the agency to reconsider its decision, also worried about potential misuse and addiction.

Senators at the hearing echoed those concerns, especially since the FDA approved Zohydro without requiring it to have properties that aim to thwart crushing or chewing of such drugs to get a high.

"The concern that I think a number of us have ... (are) about the implications of allowing this new product on the market without these abuse deterrent properties," said Senator Robert Casey, a Democrat from Pennsylvania on the panel.

Hamburg said currently approved hydrocodone drugs also contain acetaminophen, which can be toxic to the liver at higher doses. Zohydro does not contain the added pain ingredient.

Hamburg added that the agency was working on guidelines to help manufacturers come up with more effective abuse deterrents.

Abuse of OxyContin became so widespread that manufacturer Purdue Pharma changed its formula in 2010 so that the drug could not be injected or snorted as easily.

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