FDA to Hold Ad Comm Meeting for Rexulti in PTSD

The FDA plans to host a Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to review the supplemental new drug application (sNDA) for Rexulti (brexpiprazole) in combination with sertraline to treat adults with post-traumatic stress disorder (PTSD). A date has yet to be set by the FDA, but it is currently anticipated to occur during the first half of 2025.

This decision means that the Prescription Drug User Fee Act (PDUFA) target action date, originally planned for Feb. 8, 2025, will be delayed, according to Otsuka Pharmaceutical, the manufacturer of Rexulti.

About 6 six out of every 100 people will experience PTSD at some point in their lives. PTSD is a psychiatric disorder that can occur in people who have experienced or witnessed a traumatic event.

Rexulti is available to treat patients with major depressive disorder, schizophrenia and agitation associated with Alzheimer’s disease. It has a wholesale acquisition cost of $1,471.50 a month. Otsuka offers a savings card for commercially insured patients that provides for $0 refills, with a limit of $8,180 applied to patients’ annual deductible with up to 13 uses per calendar-year.

Related: PTSD Treatment Shows Promise with Brexpiprazole, Sertraline Combination

Otsuka had submitted the supplemental application in April 2024. The sNDA submission is based on data from three randomized clinical trials. The primary endpoint for all three trials was the change from randomization (week 1) to week 10 in the Clinician-Administered PTSD Scale (CAPS-5) total score for brexpiprazole and sertraline combination therapy versus sertraline plus placebo in patients diagnosed.

Across the three trials, the combination of brexpiprazole and sertraline in adult patients with PTSD was generally well-tolerated. The overall incidence of treatment-emergent adverse events (TEAEs) across the three trials was 55.5% with brexpiprazole plus sertraline, and 56.2% with sertraline plus placebo.