FDA rejects KemPharm's Apadaz

KemPharm Inc. (NASDAQ:KMPH) fell $1.79 (28%) to $4.35 in early after-hours trading Monday after it received an FDA complete response letter for Apadaz benzhydrocodone/acetaminophen ( KP201/APAP). The candidate was under review as an abuse-deterrent product for the short-term management of acute pain.

The rejection came in spite of an FDA panel's recommendation that Apadaz be approved. Last month, FDA's Anesthetic and Analgesic Drug Products and Risk Management Advisory Committees voted 16-4 the agency should approve Apadaz, but 18-2 the analgesic should not have abuse deterrent labeling (see BioCentury Extra, May 5). ...