FDA panels to discuss KemPharm's pain candidate

FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will meet on May 5 to discuss an NDA for KP201/APAP from KemPharm Inc. (NASDAQ:KMPH). The candidate is under Priority Review for the short-term management of acute pain, with a June 9 PDUFA date.

The committees are to discuss whether KemPharm has demonstrated abuse-deterrent properties that would support labeling, and whether the nasal route of abuse is relevant for hydrocodone/acetaminophen products. KP201/APAP is an oral, abuse-deterrent formulation of benzhydrocodone, a hydrocodone prodrug, and acetaminophen. ...