Apadaz benzhydrocodone/acetaminophen regulatory update

FDA issued a complete response letter to KemPharm for Apadaz benzhydrocodone/acetaminophen as an abuse-deterrent product for the short-term management of acute pain. The letter follows an FDA panel vote of 16-4 that the agency should approve Apadaz for the short-term management of acute pain but 18-2 that the treatment should not be labeled as an abuse-deterrent product (see BioCentury, May 9). KemPharm said it plans to meet with FDA to discuss a path forward for the candidate but declined to provide additional details. ...