Drugs

Rexulti/Sertraline Combo NDA for PTSD

FDA has accepted for review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) in combination with sertraline for treating adults with post-traumatic stress disorder (PTSD). The agency has set a 2/8/2025 user fee review action target date.

The submission is based on data from three randomized clinical trials. The primary endpoint for all three 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 with PTSD.

“In Trial 061 and 071, brexpiprazole in combination with sertraline was associated with a statistically significant reduction (p<0.05) in PTSD symptoms compared to sertraline plus placebo, as measured by the change in the CAPS-5 total score from randomization (Week 1) to Week 10 (primary endpoint),” the company says. “In Trial 072, while the primary endpoint was not met, reductions in PTSD symptoms with brexpiprazole in combination with sertraline were consistent with Trials 061 and 071.”

Safety data were consistent with the known profile of brexpiprazole and observed in other clinical trials. “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,” the companies say.

Brexpiprazole was approved in 2015 as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults. Last May, it was approved for treating agitation associated with dementia due to Alzheimer's disease.

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