Zogenix up on Zohydro approval

Zogenix Inc. (NASDAQ:ZGNX) jumped on Friday after FDA approved Zohydro ER hydrocodone bitartrate to manage chronic pain severe enough to require a continuous, around-the-clock opioid analgesic when alternatives are inadequate. Zogenix said it plans to launch the drug in the U.S. in about four months.

Last month, FDA announced new postmarketing requirements along with classwide labeling changes for extended-release and long-acting opioids. Zohydro -- an oral, controlled-release formulation of hydrocodone -- is the first opioid to be approved with the new labeling and requirements, which include studies to assess the risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long-term use (see BioCentury Extra, Sept. 10). ...