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ARTICLE | Company News

Zogenix neurology news

April 28, 2014 7:00 AM UTC

Massachusetts Gov. Deval Patrick said doctors are now required to check a patient's controlled-substance history through a statewide prescription monitoring program (PMP) prior to prescribing Zogenix's Zohydro ER hydrocodone bitartrate for pain drug. The program tracks dispensing information on controlled substances scheduled by the U.S. Drug Enforcement Agency as class II through class V scheduled drugs. Zohydro ER - an oral, non-abuse deterrent, extended-release (ER) formulation of hydrocodone - is a class II scheduled drug. In Massachusetts, a prescription for a class II scheduled drug can only cover a 30-day supply, so prescribers would be required to check a patient's history through the program every 30 days.

Other requirements are in line with the classwide REMS for extended-release and long-acting opioids, which covers Zohydro ER. Neither the company nor Patrick's office responded to questions about whether the state's requirements would create duplicate paperwork. FDA could not be reached for comment. ...