U.S. Federal court stays Massachusetts ban of Zogenix's painkiller

April 15 Tue Apr 15, 2014 4:10pm EDT

April 15 (Reuters) - A U.S. federal court granted Zogenix Inc a preliminary injunction against a ban blocking the sale of its controversial opioid painkiller, Zohydro, in Massachusetts, citing public interest.

Last week, the company had sought a restraining order against the ban announced by Massachusetts Governor Deval Patrick, who formally declared a public health emergency stemming from the abuse of opioids.

The U.S. District Court of Massachusetts struck down 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. (link.reuters.com/par58v)

" ... 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. For the same reason, the injunction is in the public interest," Judge Rya Zobel said.

The order is stayed until April 22.

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

Zohydro, Zogenix's sole product on the market, was approved by the FDA last year despite objections by its advisory panel, which expressed concern over the drug's potential for abuse.

The drug, an extended-release form of hydrocodone, has since come under scrutiny from members of Congress, state attorney generals, medical groups and experts seeking to block its use.

Unlike rival products such as AbbVie Inc's Vicodin or UCB's Lortab, Zogenix's Zohydro does not contain acetaminophen, a nonsteroidal anti-inflammatory drug linked to liver damage and stomach bleeding.

Zogenix has defended the drug as a necessary option for patients who cannot tolerate acetaminophen. But critics worry that with no built-in abuse deterrents, Zohydro will be a draw for addicts looking for an easy fix.

Zogenix shares closed down 4.5 percent at $2.34 on Tuesday on the 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 Natalie Grover in Bangalore; Editing by Savio D'Souza)

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Comments (1)
EMT59 wrote:
I find it hard to believe that people think adding acetaminophen to hydrocodone is going to deter addicts from using it. Even people in the health care field seem to believe this! Do you really think an abuser is going to worry about liver damage and stomach bleeding? All the acetaminophen does is create problems of potential liver and stomach damage for the people who legitimately need pain relief.

Apr 16, 2014 2:24pm EDT  --  Report as abuse
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