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Judge likely to boot Massachusetts ban of new opiate Zohydro

Judge says gov 'is out of line on this'
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Massachusetts Governor Deval Patrick

After Massachusetts Governor Deval Patrick banned Zogenix's ($ZGNX) powerful new FDA-approved painkiller, Zohydro, the company filed a lawsuit arguing the ban was unconstitutional. On Tuesday, federal district court judge Rya Zobel said she was inclined to agree with Zogenix and was leaning towards granting a preliminary injunction that would allow Zohydro to be sold in Massachusetts.

"I think, frankly, the governor is out of line on this," Zobel said from the bench, according to The Boston Globe. Zobel said she'll hand down her final decision on Monday, after lawyers representing the state and Zogenix have time to meet, but that the company will likely prevail.

Zogenix filed a lawsuit in a Boston federal court earlier this week blasting Patrick for taking a unilateral action to ban Zohydro without alerting the company first. The lawsuit alleged that Patrick failed to respond to Zogenix's request for a meeting to discuss the drug--a revelation that rankled the judge, according to the Globe.

Patrick has said he banned Zohydro because it's a pure opiate that lacks abuse-deterrent features that would stop addicts from crushing it to get high. He's far from the only state legislator to have an issue with the drug, which was approved by the FDA last fall: More than half of the states' attorneys general have asked the agency to withdraw Zohydro from the market, and Vermont recently passed an emergency order putting restrictions on how physicians prescribe it. But FDA Commissioner Margaret Hamburg continues to defend the drug, saying it was proven safe and effective and fills an important niche for the treatment of patients with severe chronic pain.

Outside the courthouse, Patrick told reporters that the ban was a response to an epidemic of addiction in Massachusetts, according to the Globe. Zohydro, he said, is "an example of highly addictive narcotic painkillers and it's one of the few that is not in an abuse-resistant form. Put it in an abuse-resistant form and I and many others will make our peace with it."

Zogenix President Stephen Farr responded by telling reporters his company had proven the drug to be safe and effective and could find no previous example of a state overruling a decision by the FDA. Farr told reporters Patrick's ban was not just harming the company but was "certainly hurting the patients of Massachusetts." In a statement, Zogenix said it would continue to monitor and evaluate all state-based actions regarding Zohydro to ensure the drug receives "equal treatment for any rules that impact patient access and prescribing."

- here's the statement from Zogenix
- see the Boston Globe story
- read more at the Boston Herald

Related Articles:
Zogenix sues Massachusetts over ban on controversial painkiller Zohydro
Massachusetts bans Zogenix's controversial new painkiller Zohydro
Under fire, FDA chief Hamburg defends approval of pain pill Zohydro

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