FDA Adviser Panel Votes Against Efficacy Of Otsuka’s Combination Treatment For Adults With PTSD

Reuters (7/18, Sunny, Mahatole) reported the FDA’s “panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma’s antipsychotic drug in combination with Viatris’ antidepressant Zoloft [sertraline hydrochloride] for treating adults with PTSD.” The FDA “panel voted 10-1 to say the available data does not establish the efficacy of the drug, brexpiprazole, in combination with Zoloft…for treating the condition.” The panel’s “decision is in line with the FDA staff reviewers’ assessment on Wednesday.

Related Links:

— “US FDA advisers recommend against Otsuka’s PTSD combination treatment,”Mariam E Sunny and Siddhi Mahatole, Reuters, July 18, 2025

Posted in In The News.