Reviewers Question Otsuka PTSD Drug Efficacy

In advance of a 7/18 Psychopharmacologic Drugs Advisory Committee meeting, FDA has released a briefing document questioning the efficacy of Otsuka’s brexpiprazole, whose NDA will be considered by the committee as a treatment for post-traumatic stress disorder (PTSD). Otsuka is proposing to use brexpiprazole (Rexulti) in combination with sertraline (Zoloft) to treat PTSD.

Agency medical reviewers cite inconsistent trial results and a modest treatment effect that they say may not be clinically meaningful as reasons for raising the efficacy concerns.

Rexulti is approved by FDA to treat agitation in patients with Alzheimer’s disease and for adults with major depressive disorder and schizophrenia. Committee members will be asked to consider the conflicting trial results and decide whether the available data establish the efficacy of Rexulti, when initiated concurrently with Zoloft, to treat PTSD.