The Psychopharmacologic Drugs Advisory Committee of the FDA is set to meet on July 18 to consider a supplemental new drug application for brexpiprazole (Rexulti, Otsuka Pharmaceutical Co., Ltd.), in combination with sertraline, for the treatment of adults with posttraumatic stress disorder (PTSD).

If approved, it would be the first new treatment for PTSD in more than 20 years.

Why Brexpiprazole Plus Sertraline?

Brexpiprazole is an atypical antipsychotic currently approved as adjunctive treatment of major depressive disorder (MDD) in adults; treatment of schizophrenia in adults and adolescents aged 13 years or older; and treatment of agitation associated with Alzheimer’s dementia.

The combination of brexpiprazole and sertraline could address the limitations of SSRI alone by working synergistically to treat PTSD.

“It is my hope that the FDA does approve this treatment for two related reasons — the data look positive and compelling, and there’s a tremendous unmet need in PTSD,” Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the Mood Disorders Psychopharmacology Unit, University of Toronto, Toronto, Ontario, Canada, told Medscape Medical News.

Source: MEDspace