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Gillibrand challenges FDA OK of hydrocodone drug

Sen. Kirsten Gillibrand. (June 4, 2013)

Sen. Kirsten Gillibrand. (June 4, 2013) Photo Credit: Getty Images

Kirsten Gillibrand and other U.S. senators are asking the Food and Drug Administration to explain why it approved a potent painkiller that's easily abused, ignoring an advisory panel's recommendations.

Gillibrand made her demand Friday in a letter to FDA Commissioner Margaret Hamburg that was cosigned by Democratic Sens. Dianne Feinstein of California, Amy Klobuchar of Minnesota and Joe Manchin of West Virginia.

Amid the current prescription drug epidemic, "this will only contribute to the rising toll of addiction and death," the senators said.

The current formula for Zohydro releases pure hydrocodone over time, but the pills can be smashed. That enables people to get high faster by inhaling it or using a syringe, experts said.

Three years ago, the maker of another often-abused painkiller, OxyContin, made its pills impossible to pulverize. Abuse and misuse of the drug has fallen 50 percent since then, the senators said.

It was irresponsible of the FDA to approve Zohydro without similar safeguards, they said.

FDA spokesman Morgan Liscinsky said in an email Friday that "abuse-deterrent formulations" are simply not available for some extended release painkillers.

The San Diego-based manufacturer, Zogenix Inc., had no immediate comment. Zogenix president Stephen Farr said last month that it had "started the development of an abuse-deterrent formulation of Zohydro ER, and we are committed to advancing the program as rapidly as possible."

The FDA has said Zohydro should only be used to treat pain severe enough to require "daily, around-the-clock, long-term treatment" that can't be addressed with other drugs.

The new opiod drug is 5 to 10 times more potent than Vicodin, the senators said. When Zohydro hits the market early next year, it will be the first pure hydrocodone sold in the United States. Abuse concerns led an FDA advisory panel last December to vote 11-2 against Zohydro.

In 2012, hydrocodone played a role in at least 20 overdose deaths in Suffolk County, and at least seven in Nassau.


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