H. Lundbeck A/S (Lundbeck) and Otsuka America Pharmaceutical Inc., (Otsuka) announced that Otsuka has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for use of REXULTI®? (brexpiprazole) in combination with sertraline as a treatment of adults with post-traumatic stress disorder (PTSD). The CRL states that the FDA has completed their review but cannot approve the application in the current form, as the application does not provide substantial evidence of effectiveness to support the approval.
The sNDA for brexpiprazole in combination with sertralines for the treatment of adults with PTSD was accepted for review by the FDA in June 2024 and was based on data from three randomized clinical trials that evaluated the safety and efficacy of brexpiprazole in combined with sertraline in adult patients with PTSD. The FDA decision follows the Psychopharmacologic Drugs Advisory Committee Meeting on July 18, 2025. The committee voted 1-10 determining that the efficacy of brexpipraz Hole, when initiated concurrently with sertraline, has not been established for the treatment of PTSD based on the available data presented.
Although data from three clinical studies were submitted, the FDA stated in the CRL that not all of these studies are capable of contributing to the substantial evidence of the submission and should Otsuka and Lundbeck be interested in proceeding with the indication, additional positive, adequate and well-controlled trials would be needed to provide substantial evidence of effectiveness. Pharmacotherapy with certain antidepressants is recommended when these trauma-focused psychotherapies are not available or feasible when patients prefer medications.
