Zogenix stock up on Zohydro update

Zogenix Inc. (NASDAQ:ZGNX) rose $0.29 (15%) to $2.24 on Wednesday after announcing FDA informed it that an action letter for pain product Zohydro ER hydrocodone bitartrate could follow after a "further delay of short duration." Zogenix indicated the timing for a decision may be affected by the government shutdown. On Tuesday, FDA said it will continue to review applications submitted prior to the government shutdown and may issue new approvals. The company said the agency previously indicated it would take action "over the summer." The oral controlled-release formulation of hydrocodone had a March 1 PDUFA date.

Zogenix also said it had agreed with FDA on labeling and postmarketing requirements. Last month, the agency announced new classwide postmarket study requirements for extended-release and long-acting opioids (see BioCentury Extra, Sept. 10). ...