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Attorney generals urge FDA to rethink approval of Zohydro

posted Dec 21, 2013, 5:52 PM by Victor   [ updated Dec 21, 2013, 5:58 PM ]
December 21, 2013

Back in October, Zogenix Inc. received approval from the Food and Drug Administration for an extended-release formulation of hydrocodone, Zohydro ER. Zohydro ER would be the first pure hydrocodone medication to be marketed in the United States. Late last week, however, a coalition of attorney generals from 28 states asked the FDA to reconsider its decision to approve Zohydro ER. In the U.S., hydrocodone is currently only available in combination formulations containing other drugs such as acetaminophen. Concerns have been raised over the abuse potential of Zohydro ER, which in its current form contains no anti-abuse mechanisms and can be easily crushed.
State AGs urge FDA to rethink approval of painkiller Zohydro
Reuters - December 12, 2013


Attorney generals from 28 U.S. states have asked the Food and Drug Administration to reconsider its approval of the powerful painkiller Zohydro ER, which Kentucky's top law enforcement official said could start an epidemic of abuse.

The drug, manufactured by Zogenix Inc of San Diego, was approved by the FDA in October.

In December 2012 a panel of outside experts convened by the agency had voted 11-2 against the drug's approval, citing its potential to cause addiction.

Kentucky Attorney General Jack Conway said his state had been hurt by abuse of prescription painkillers, especially OxyContin, and he feared more problems with Zohydro ER.

"The approval of this very potent drug is troubling because, unlike extended-release opioids containing abuse-deterrent properties, there is nothing that would prevent someone from easily crushing or injecting Zohydro ER to get high," Conway said.

Conway joined attorneys general from 27 states and the U.S. territory of Guam in signing a letter to FDA Commissioner Margaret Hamburg, dated Tuesday, asking that approval of Zohydro be reconsidered or that the drug be reformulated with chemical deterrents to abuse.

"State attorneys general do not want a repeat of the recent past when potent prescription painkilling drugs entered the market without abuse-deterrent qualities and without clear guidance on how they were to be prescribed," the letter said.

The attorneys general said Zohydro reportedly is five to 10 times more potent than standard hydrocodone products.

The FDA approved the drug for daily, long-term treatment for which other options were inadequate. FDA spokeswoman Morgan Liscinsky said the agency would review the attorneys generals' letter and respond.

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.

Continue reading at Reuters...