FDA staff raises efficacy concerns for Otsuka's PTSD combination drug

H Lundbeck A/S

16/07/2025 14:10

July 16 (Reuters) - The U.S. Food and Drug Administration's staff reviewers on Wednesday raised efficacy concerns over Otsuka Pharma's 4578.T combination treatment for adults with post-traumatic stress disorder (PTSD), citing inconsistent trial results and a modest treatment effect that may not be clinically meaningful.

 (Reporting by Siddhi Mahatole and Mariam Sunny in Bengaluru; Editing by Shailesh Kuber and Shreya Biswas)

 ((siddhi.mahatole@thomsonreuters.com;))