Zogenix announced that it is taking legal action against the ban imposed by Massachusetts Governor Deval Patrick on Zohydro ER, a move that the company calls “improper.”
The lawsuit was filed in the U.S. District Court of Massachusetts asking for a temporary restraining order against the implementation of the governor’s executive order. In the latest of state and federal efforts to restrict access to Zohydro ER, Governor Patrick has issued a state ban on the drug on the grounds of a public health crisis declaration. “Zohydro is a dangerously addictive pharmaceutical painkiller, approved by the FDA recently over the objection of their scientific advisory council and is not available in an abuse-deterrent form. Unless it is available in an abuse-deterrent form, or better, until the secretary of [Health and Human Services], or the Congress has acted on the requests to overturn the FDA, Zohydro will not be available in Massachusetts,” stated Governor Patrick.
Zohydro ER is an FDA-approved opioid agonist, extended-release, oral formulation of hydrocodone bitartrate. The drug is indicated for the management of severe pain requiring daily, round-the-clock, and long term opioid treatment, and for which, no alternative treatment options are present.
Roger Hawley, CEO of Zogenix, said, “Governor Patrick's unilateral action was taken without any communication or advanced notice. In very limited interactions with his staff after the decision, we are convinced the decision was driven by factual inaccuracies about the science and the data. Unfortunately, it left us little recourse but to put the needs of patients in severe chronic pain ahead of politics and file for an injunction to stop the executive order. Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical trial data. This rigorous FDA review process serves the nation's public health needs, the medical community and those in severe chronic pain, and the FDA regulatory authority simply should not be usurped by individual states.”
The company’s legal action came after a formal written request for a meeting with the Governor met with no response. Zogenix said it wanted to discuss facts about Zohydro with Governor Patrick but was led to pursue legal action to put the needs of patients over politics.