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BioWorld - Wednesday, June 10, 2026
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Home » Adcom agrees with FDA: Otsuka’s PTSD treatment needs more study
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Adcom agrees with FDA: Otsuka’s PTSD treatment needs more study

July 22, 2025
By Lee Landenberger
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In a 10-1 vote, the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said Otsuka Pharmaceutical Co. Ltd.’s studies of its combination post-traumatic stress disorder (PTSD) treatment did not show enough efficacy. Had the adcom felt otherwise, the path may have been smoother for a new treatment in an indication that hasn’t seen regulatory advancement in decades. The committee’s conclusion, however, is not binding on the FDA, which will make its own decision whether to approve.
BioWorld Asia Regulatory Neurology/psychiatric Bispecific antibody U.S. FDA PDUFA

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