The FDA’s Psychopharmacologic Drugs Advisory Committee voted overwhelmingly against approval of Otsuka Pharmaceutical’s combination of Rexulti with sertraline (Zoloft) for post-traumatic stress disorder treatment. The decision reflects concerns from a failed Phase 3 trial alongside issues that both drug components are already approved antidepressants with limited additive efficacy evidence. The FDA and advisory committee seek more robust data to support efficacy claims before approval. Otsuka's PTSD supplemental new drug application remains under review with uncertain prospects.