Trevena reports Complete Response Letter for oliceridine from FDA
Trevena announced the company has received a Complete Response Letter, or CRL, from the U.S. Food and Drug Administration regarding the New Drug Application for oliceridine. Consistent with the discussion at the recent Advisory Committee meeting, FDA has requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing. FDA also requested certain additional nonclinical data and validation reports. "While we are disappointed with FDA's decision, we continue to believe in the strength of the data and the ultimate approvability of oliceridine. We plan to schedule a follow-up meeting with FDA as soon as possible with the goal of bringing this important medicine to clinicians and hospital patients," said CEO Carrie Bourdow. "Developing a novel chemical entity is complex, and we believe the data we have to support oliceridine advances the pharmacology of acute pain therapeutics. We were encouraged by the discussion at the Advisory Committee meeting and look forward to continuing a productive dialogue with FDA," said Mark A. Demitrack, M.D., SVP and Chief Medical Officer.