Zogenix, U.S. Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS) neurology news
Sen. Joe Manchin (D-W.Va.) introduced a bill in the U.S. Senate to withdraw FDA's approval of Zogenix' Zohydro ER hydrocodone bitartrate due to its "high potential for misuse and abuse." The bill has been referred to the Committee on Health, Education, Labor, and Pensions Manchin had sent letters to HHS Secretary Kathleen Sebelius and FDA commissioner Margaret Hamburg to overturn the approval. In a statement Manchin said "their refusal to budge forces me to introduce legislation." Sen. Charles Schumer (D-N.Y.) also sent a letter to Sebelius earlier this month asking HHS to overturn Zohydro's approval. HHS said it will respond.
FDA approved Zohydro - a non-abuse-deterrent, controlledrelease 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 (see BioCentury, Dec. 10, 2012). ...