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GEN News Highlights : Apr 16, 2014
Zogenix Wins Round 1 in Legal Bout with Massachusetts
Zogenix won the first battle in its legal wrangle with Massachusetts when a federal judge yesterday temporarily blocked the state from enforcing its nearly two-week-old ban on Zohydro™ ER (hydrocodone bitartrate) extended-release (ER) capsules.
U.S. District Court Judge Rya Zobel issued a preliminary injunction set to take effect April 22. The preliminary injunction came about a week after Zogenix sued Massachusetts in federal court, arguing that Gov. Deval Patrick (D) acted unconstitutionally when he signed an executive order on March 27 banning the prescribing and dispensing of the company's prescription pain product despite its approval by the U.S. Food and Drug Administration (FDA).
Zobel concluded that the ban would “undermine the FDA’s ability to make drugs available to promote and protect the public health” as envisioned when Congress created the agency more than a century ago. She said Massachusetts exceeded its authority in banning Zohydro, citing a need to protect public health, and that Zogenix was likely to prevail in an anticipated request to grant a permanent injunction against the state.
“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,” Zobel wrote.
Zogenix hailed Zobel’s decision.
"Today's legal ruling was a positive step forward for Massachusetts patients," Zogenix CEO Roger Hawley said Tuesday in a company statement. "We invite concerned officials to engage with us to discuss fair and appropriate safeguards for pain medications like Zohydro ER rather than seeking to ban or restrict one specific treatment."
Patrick issued his own statement expressing disappointment that Zobel placed Zogenix’ commercial interests over what he said was Massachusetts’ interests in protecting public health.
Patrick banned Zohydro after declaring a public health emergency, citing what he termed an epidemic of opioid abuse resulting in overdose deaths and overdoses. At the time, he said the ban would last until the state was satisfied that measures existed to “safeguard against the potential for diversion, overdose, and misuse” of the painkiller.
He noted that Zogenix didn’t design Zohydro ER with an abuse-deterrent formulation, as FDA required for OxyContin (oxycodone). The potential for abuse was cited by an FDA advisory panel, but it did not sway the agency, which approved the drug for market on October 25.
“Addiction is a serious enough problem already in Massachusetts without having to deal with another addictive narcotic painkiller sold in a form that isn’t tamper-proof,” Patrick said. “We will turn our attention now to other means to address this public health crisis.”
Zobel noted that Patrick offered to allow Zohydro sales if Zogenix marketed a tamper-proof version of the pain drug—an action the judge said would wrongly force the company to return to the FDA since that version of Zohydro differs from the one approved by the agency.
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