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Senators ask Sebelius to overturn Zohydro approval

March 12, 2014 12:42 AM UTC

Sen. Joe Manchin (D-W.Va.) became the second senator to call for HHS Secretary Kathleen Sebelius to overturn FDA's approval of Zohydro ER hydrocodone bitartrate from Zogenix Inc. (NASDAQ:ZGNX) because of the pain drug's "high potential for abuse." Last week, Sen. Charles Schumer (D-N.Y.) also sent a letter to Sebelius asking HHS to overturn Zohydro's approval. HHS said it will respond.

FDA approved Zohydro -- a non-abuse-deterrent, controlled-release formulation of hydrocodone -- in October to manage chronic pain severe enough to require a continuous, around-the-clock opioid analgesic when alternatives are inadequate. An advisory committee had recommended against approval due to concerns about the effectiveness of the classwide REMS for extended-release and long-acting opioids; the panel's prime concern was Zohydro's abuse potential. Zogenix launched Zohydro in select pharmacies last week (see BioCentury, Dec. 17, 2012). ...