Lundbeck, Otsuka combo meets in Phase II for PTSD

H. Lundbeck A/S (CSE:LUN) and Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) said a combination of brexpiprazole and the generic serotonin reuptake inhibitor (SSRI) sertraline met the primary endpoint in a Phase II trial to treat posttraumatic stress disorder (PTSD). The partners plan to meet with FDA next year to discuss the data and next steps for the program.

The double-blind, U.S. trial enrolled 321 patients to receive placebo, flexible doses of brexpiprazole monotherapy, flexible doses of sertraline monotherapy or combination therapy with brexpiprazole and sertraline. On the primary endpoint, the combination significantly improved Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score from baseline to week 12 vs. placebo (p<0.01). Both monotherapy arms missed the endpoint...