Concerns about the high potential for abuse prompt an FDA advisory panel to vote against approval of Zohydro ER, an extended-release, single-ingredient capsule formulation of hydrocodone, for the treatment of chronic pain.
SILVER SPRING, MD—The majority of an FDA advisory panel voted against approval of an extended-release, single-ingredient capsule formulation of hydrocodone for the treatment of chronic pain, citing the need for a tamper-proof formulation and a stronger risk-mitigation strategy to address the high potential for abuse and misuse of the product.
At a December 7, 2012, meeting of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, the panelists voted 11 to 2, with 1 abstention, against approval of the product, although they agreed that the manufacturer had met the current standards for approval for the proposed indication—the management of moderate to severe chronic pain when a continuous around-the-clock opioid analgesic is needed for an extended period. However, concerns about the potential public health impact of the availability of an extended-release formulation of hydrocodone that does not contain acetaminophen—which would make it more attractive as a drug of abuse, particularly for IV drug abusers—or a tamper-resistant design, swayed their votes.
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