Neurobehavioral Disorders

Brexpiprazole Plus Sertraline Under Review for Post-Traumatic Stress Disorder

Brian Park, PharmD
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Publish Date
A regulatory decision on the combination therapy is expected on February 8, 2025.

The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD).

The sNDA is supported by data from 3 clinical trials (ClinicalTrials.gov Identifier: NCT03033069 [Trial 061], NCT04124614 [Trial 071], NCT04174170 [Trial 072]), which evaluated the efficacy and safety of brexpiprazole vs placebo in combination with sertraline in adult patients with PTSD. The primary endpoint for all studies was the change from week 1 to week 10 in the Clinician-Administered PTSD Scale (CAPS-5) total score.

Findings from Trial 061 and 071 showed patients who received brexpiprazole plus sertraline experienced a statistically significant reduction in PTSD symptoms compared with sertraline plus placebo (P <.05). The combination was also associated with improvements in Clinical Global Impression Severity score and the four CAPS-5 clusters of re-experiencing, avoidance, negative cognition/mood and arousal/reactivity symptoms. 

In Trial 072, treatment with brexpiprazole plus sertraline did not result in a statistically significant change in CAPS-5 total score compared with placebo and sertraline.

No new safety signals were identified across these 3 trials. 

“Brexpiprazole in combination with sertraline could represent an important advancement over current standard of care, and we look forward to working with the FDA in the process of seeking approval of this combination,” said Johan Luthman, PhD, executive vice president, Lundbeck Research & Development. 

A Prescription Drug User Fee Act target date of February 8, 2025 has been assigned to the application.

Brexpiprazole, an atypical antipsychotic, is currently marketed under the brand name Rexulti for: treatment of agitation associated with dementia due to Alzheimer disease; use as an adjunctive therapy to antidepressants for major depressive disorder (MDD); and treatment of schizophrenia.

Sertraline, a selective serotonin reuptake inhibitor, is currently marketed under the brand name Zoloft for the treatment of MDD, obsessive-compulsive disorder, panic disorder, PTSD, social anxiety disorder, and premenstrual dysphoric disorder.

This article originally appeared on MPR

References:

Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). News release. Otsuka and Lundbeck. June 25, 2024. https://www.businesswire.com/news/home/20240625407910/en/Otsuka-and-Lundbeck-Announce-FDA-Acceptance-of-sNDA-Filing-for-Brexpiprazole-in-Combination-With-Sertraline-for-the-Treatment-of-Adults-With-Post-Traumatic-Stress-Disorder-PTSD.