US court reverses Massachusetts ban on Zogenix opioid

by Reuters
Tuesday, 15 April 2014 21:42 GMT

By Susan Kelly and Natalie Grover

April 15 (Reuters) - A U.S. District Court judge on Tuesday stopped Massachusetts from implementing a ban on the sale of Zogenix Inc's prescription painkiller Zohydro, saying federal law superceded the state's action.

Massachusetts Governor Deval Patrick had announced a ban on the drug, formally declaring a public health emergency on March 27 stemming from abuse of opioids in the New England state.

The U.S. District Court for Massachusetts granted a preliminary injunction against the ban, saying that by imposing its own conclusion about the safety and efficacy of Zohydro, the state was obstructing the U.S. Food and Drug Administration's constitutionally mandated charge.

The federal court order goes into effect on April 22.

"Although the ban may prevent someone from misusing the drug, the ban prevents all in need of its special attributes from receiving the pain relief Zohydro ER offers," Judge Rya Zobel said.

The injunction comes in the midst of a furor over Zohydro as the United States grapples with a rise in opioid abuse. The class of drugs includes not only powerful prescription painkillers but also heroin.

Zohydro, an extended-release form of hydrocodone, has come under scrutiny from members of Congress, state attorneys general, medical groups and drug treatment experts seeking to block its use.

FDA last year approved Zohydro, Zogenix's sole product on the market, despite concerns from an advisory panel over the drug's potential for abuse.

Zogenix maintains the drug is a necessary option for patients who cannot tolerate acetaminophen.

"Today's legal ruling was a positive step forward for Massachusetts patients," said Zogenix Chief Executive Roger Hawley.

Unlike competing products such as AbbVie Inc's Vicodin and UCB's Lortab, Zohydro does not contain acetaminophen, which has been linked to liver damage and stomach bleeding.

FDA, in a statement, said it is following the legal proceedings in Massachusetts and remains concerned about efforts by states to ban FDA-approved drugs.

"Both the prevention of prescription opioid abuse and appropriate pain management are top public health priorities at FDA. Actions to advance one should not impede the other," the agency said.

Zogenix shares closed down 11 cents, or 4.5 percent, at $2.34 on Tuesday on Nasdaq.

The case was in Re: Zogenix Inc vs Deval Patrick in the U.S. District Court, District of Massachusetts, No. 14-11689-RWZ (Reporting by Susan Kelly in Chicago and Natalie Grover in Bangalore; Additional reporting by Toni Clarke in Washington; Editing by Savio D'Souza and Jonathan Oatis)

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