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Massachusetts requiring patient history check for Zohydro

April 24, 2014 12:33 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 pain drug Zohydro ER hydrocodone bitartrate from Zogenix Inc. (NASDAQ:ZGNX). The program tracks dispensing information on controlled substances scheduled by the U.S. Drug Enforcement Agency as class II though 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. ...