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