Alkermes, Zogenix neurology news
Zogenix filed suit challenging Massachusetts Gov. Deval Patrick's executive order banning the prescription or distribution of pain drug Zohydro ER hydrocodone bitartrate. Zogenix filed the suit against Patrick and Cheryl Bartlett, commissioner of the Massachusetts Department of Public Health, in the U.S. District Court for the District of Massachusetts. 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. Zogenix launched Zohydro ER - an oral, non-abuse deterrent, extended-release (ER) formulation of hydrocodone - in select pharmacies in March (see BioCentury, March 31).
In its complaint, Zogenix calls the ban an "impermissible effort by Massachusetts to establish its own drug approval policy" and argues it is in direct conflict with FDA's authority and undermines the agency's assessment that Zohydro ER is a safe and effective drug. Zogenix said it has presented its case to the court for a motion for an immediate stay on the ban. The court will hold a follow-up hearing on April 14. The company is also seeking a permanent injunction. ...