ARTICLE | Company News

Zogenix challenging Massachusetts' Zohydro ban

April 8, 2014 1:26 AM UTC

Zogenix Inc. (NASDAQ:ZGNX) filed suit against Massachusetts Gov. Deval Patrick and Cheryl Bartlett, commissioner of the Massachusetts Department of Public Health, in the U.S. District Court for the District of Massachusetts challenging Patrick's executive order banning the prescription or distribution of pain drug Zohydro ER hydrocodone bitartrate. On March 28, Patrick declared opiate addiction a public health emergency and directed state authorities to immediately prohibit the prescription or sale of Zohydro ER until FDA approves an abuse deterrent formulation. Zohydro ER is an oral, non-abuse deterrent extended-release (ER) formulation of hydrocodone (see BioCentury Extra, March 28).

Zogenix said Patrick's ban is an "impermissible effort by Massachusetts to establish its own drug approval policy." The company said the ban is in direct conflict with FDA's authority and undermines the agency's assessment that Zohydro ER is a safe and effective drug. The court is scheduled to hear Zogenix's motions for a temporary restraining order and injunctions against the executive order on Tuesday. ...