Phase 2 Results for Lundbeck and Otsuka PTSD Combo Therapy Suggest Efficacy

Patients with posttraumatic stress disorder (PTSD) appear to experience greater symptom improvements when taking a combination of brexpiprazole and sertraline than those taking either medication alone, suggest the findings of a phase 2 trial. H. Lundbeck and Otsuka Pharmaceutical Co. Ltd. announced the results in November.

The trial, which involved 321 patients, assessed the efficacy, safety, and tolerability of monotherapy with either brexpiprazole or sertraline and therapy with both agents combined compared with placebo. The patients were evaluated using the Clinician-Administered PTSD Scale for DSM-5 at the beginning and end of the trial.

The companies plan to discuss the results with the Food and Drug Administration (FDA) and to evaluate, with the FDA, the continuation of a trial program. ■