FDA staff raises efficacy concerns for Otsuka's PTSD combination drug
ReutersJul 16, 2025 1:10 PM
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.
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