KemPharm Plans To License Out Commercial Rights For Pain, ADHD Candidates

On the verge of obtaining its first product approval from the US FDA in February and now moving a second candidate into Phase III, KemPharm Inc. has determined that rather than commercializing its products, it will rely on partners while it focuses on using its technology platform to create prodrugs of already-approved molecules.

Previously stalled due to an FDA complete response letter, Apadaz (benzohydrocodone/acetaminophen), intended as an abuse-deterrent therapy for acute pain, now has a Feb. 23 user fee date after the Coralville, Iowa-based firm successfully used FDA’s formal dispute resolution process to clarify what it needed to do to refile its application requesting an abuse-deterrence claim