H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) have submitted a supplemental New Drug Application (sNDA) for U.S. Food and Drug Administration (FDA) review of brexpiprazole as combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD) in adults. FDA validation of the submission dossier prior to the FDA's decision whether to proceed with a full review is expected to take 60 or 74 days depending on whether FDA assigns priority or standard review. The sNDA submission is based on previously disclosed results, including data from the two clinical phase III trials (#071 flexible dose trial n=416[i] and #072 fixed-dose trial (n=553[ii])), and the clinical phase II (#061 flexible dose trial n=321[iii]).

All three trials investigated the treatment of PTSD in adults treated with brexpiprazole in combination with sertraline versus sertraline plus placebo. The primary endpoint for all three trials was the change from Week 1 to Week 10 in the Clinician-Administered PTSD Scale (CAPS-5) total score for brexpiprazole and sertraline combination therapy versus sertraline plus placebo at Week 10 in patients diagnosed with PTSD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Trial #071 and trial #061 demonstrated that the combination treatment of brexpiprazole and sertraline was superior to treatment with sertraline plus placebo.

Although trial #072 did not demonstrate superiority of the combination treatment of brexpiprazole and sertraline compared to treatment with sertraline plus placebo, the change from baseline observed in the combination group (brexpiprazole and sertraline) was consistent with the reductions observed in trials #071 and #061. Brexpiprazole in combination with sertraline was observed to be generally well-tolerated and the safety results of the three trials were consistent with the known safety profile of brexpiprazole. Lundbeck and Otsuka intend to present detailed data from all three trials at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, 28 - 31 May 2024 in Miami, Florida.