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The Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 10-1 against the approval of brexpiprazole in combination with sertraline for the treatment of adults ...

Several concerns about this study must be noted. First, the dose of sertraline was low, and dose escalations were not allowed (however, 80% of serotonin reuptake is inhibited at doses of 50 mg daily).

The U.S. Food and Drug Administration's reviewers on Wednesday raised efficacy concerns over the use of Otsuka Pharma's drug in combination with Viatris' Zoloft for the treatment of adults with PTSD.