The FDA Psychopharmacologic Drugs Advisory Committee voted 10-1 against the approval of Otsuka Pharmaceutical's combination therapy of Rexulti and Zoloft for PTSD treatment. Committee members expressed concerns about failed phase 3 trial results and inadequate efficacy data, noting that both drugs are already individually approved but the combination lacked robust supportive evidence. The FDA has also requested additional trial data to substantiate claims of efficacy. The panel's decision underscores regulators' cautious stance on new psychiatric therapeutics seeking expanded indications amid mixed clinical results.