KemPharm's Opioid Apadaz Will Likely Miss Out On Abuse Deterrence Claim

KemPharm Inc.'s chance of standing out from the pack of immediate release opioids seems unlikely following an FDA advisory committee vote against approval of abuse deterrence labeling for its Apadaz (hydrocodone/acetaminophen).

At a May 5 meeting, FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 16 to 4 for approval of the opioid for management of acute pain. But it voted 18 to 2 that it should not be labeled as an abuse deterrent product