
Data showed that brexpiprazole plus sertraline significantly improved PTSD symptoms vs sertraline alone. Lead author, Lori Davis, MD, discusses more.


FDA Advisory Committee Casts Nearly Unanimous Vote Against Otsuka's PTSD Combination

Otsuka and Lundbeck Will Face Scrutiny Over Investigational PTSD Therapy at July 18 FDA AdComm Meeting

Data showed that brexpiprazole plus sertraline significantly improved PTSD symptoms vs sertraline alone. Lead author, Lori Davis, MD, discusses more.

The adcomm meeting is expected to happen in the first half of 2025, and means the FDA expects to miss the target PDUFA date.

The sNDA for the brexpiprazole plus sertraline therapy is based on positive phase 2 and 3 clinical trials showing improvement in PTSD-specific scale scores.