The FDA’s Psychopharmacologic Drugs Advisory Committee is evaluating a New Drug Application (NDA) for a combination of brexpiprazole and sertraline as a potential treatment for posttraumatic stress disorder (PTSD). If approved, it would mark the first new PTSD therapy in more than two decades. Current options—mainly selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine—often provide limited relief.
In a phase 3 trial involving 416 adults, the brexpiprazole-sertraline combination demonstrated significantly greater improvement in PTSD symptoms compared to sertraline alone. These improvements were measured using the Clinician-Administered PTSD Scale for DSM-5, with additional benefits observed in anxiety and depression symptoms commonly associated with PTSD.
The safety profile was in line with previously known effects of brexpiprazole, although some participants experienced weight gain and sedation. These findings underscore the urgent need for more effective PTSD treatments and suggest that this combination could offer a meaningful advance.
From Medscape
