FDA panel rebuffs Zohydro ER

FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 11-2 with one abstention against approval of Zohydro ER hydrocodone bitartrate from Zogenix Inc. (NASDAQ:ZGNX) to manage moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The panel voted 8-5, with one abstention, that Zohydro ER was effective, but voted 9-5 that the company did not show the oral controlled-release formulation of hydrocodone is safe. The product has a March 1, 2013, PDUFA date.

The panel's prime concern was abuse potential. While the committee did not think the postmarketing experience of Zohydro ER would differ significantly from other opioids in the same class, most panel members who voted against approval wanted to see the existing classwide REMS for extended-release and long-acting opioids expanded to include additional safeguards, including restricted prescribing, mandatory education of prescribers, locked storage containers in patients' homes and surveillance to ensure compliance. In July, FDA approved a classwide REMS that requires companies to make educational programs available to prescribers at no or nominal cost but does not require prescribers to participate (see BioCentury Extra, July 9, 2012). ...