Safety and Tolerability of Brexpiprazole in Combination With Sertraline for Patients With Post-Traumatic Stress Disorder: Summary of Data From Phase 2 and Phase 3 Randomized Clinical Trials

A well-tolerated pharmacotherapy with consistent efficacy is needed for PTSD. This report summarizes safety data from three PTSD trials of brexpiprazole + sertraline.
Trials 061 (Phase 2; NCT03033069), 071 (Phase 3; NCT04124614), and 072 (Phase 3; NCT04174170) enrolled outpatients aged 18–65 with PTSD and symptoms for ≥6 months. All trials included an 11-week double-blind treatment period, and brexpiprazole + sertraline and sertraline + placebo treatment arms. Standard safety assessments were conducted. Data are presented per trial, and pooled (across all trials and doses), for brexpiprazole + sertraline and sertraline + placebo.
In Trial 061, treatment-emergent adverse event (TEAE) incidence was 72.5% with brexpiprazole + sertraline, and 69.6% with sertraline + placebo. In Trial 071, TEAE incidence was 60.0% and 58.2%, respectively. In Trial 072, TEAE incidence was 51.4% with brexpiprazole 2 mg/day + sertraline, 48.3% with brexpiprazole 3 mg/day + sertraline, and 51.2% with sertraline + placebo. Across the three trials pooled (brexpiprazole + sertraline, n=650; sertraline + placebo, n=447), TEAE incidence was 55.5% (brexpiprazole + sertraline), and 56.2% (sertraline + placebo). TEAEs with incidence ≥5% in either pooled group (brexpiprazole + sertraline; sertraline + placebo) were nausea (8.0%; 11.2%), headache (5.5%; 7.6%), weight increased (5.2%; 1.3%), and diarrhea (4.8%; 6.0%). Suicidality TEAE incidence (pooled) was 0.6% and 1.1%, respectively. Mean 12-week change in body weight was +1.5 kg and -0.2 kg, respectively. Three deaths occurred (brexpiprazole + sertraline, n=1); none considered related to study treatment.
No new safety observations were identified with brexpiprazole in combination with sertraline.