FDA reviewers: Zohydro likely to have 'higher levels of abuse'

FDA reviewers said they expect Zohydro ER hydrocodone bitartrate from Zogenix Inc. (NASDAQ:ZGNX) "will be associated with higher levels of abuse" than hydrocodone combination products. The comments came in briefing documents released ahead of a Friday meeting of the agency's Anesthetic and Analgesic Drug Products Advisory Committee to discuss an NDA for the pain product. The reviewers also noted that there is a "substantial" difference in the number of emergency room visits between oxycodone combination products (24 visits per million tablets dispensed) and single-entity oxycodone products (85 visits per million tablets dispensed). The reviewers said "it is likely that similar patterns will be observed" between hydrocodone combination products and Zohydro. There were 14 emergency room visits per million tablets dispensed for hydrocodone combination products.

FDA is asking the committee to discuss whether the data for Zohydro "suggest that the postmarketing experience concerning abuse" will be different than with other extended-release opioids. The committee also will be asked to discuss whether Zohydro's data support the need for additional postmarketing requirements beyond the classwide REMS that FDA approved in July for extended-release and long-acting opioids (see BioCentury Extra, July 9). ...