Otsuka and Lundbeck Reveal Brexpiprazole-Sertraline Trial Results for Adult PTSD

Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck Pharmaceuticals LLC recently shared promising results from their Phase II (Trial 061) and Phase III (Trials 071 and 072) clinical investigations on the combination of brexpiprazole and sertraline for treating post-traumatic stress disorder (PTSD) in adults. These findings were showcased at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami.

The primary endpoint for these studies was the change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score from Week 1 to Week 10. CAPS-5 is a structured interview tool used to assess the severity of PTSD symptoms, categorized into four clusters: re-experiencing, avoidance, negative cognition/mood, and arousal/reactivity. The combination therapy of brexpiprazole and sertraline showed significant improvement in two out of the three trials compared to sertraline plus placebo. The trials were designed to be randomized, double-blind, and active-controlled, ensuring rigorous testing standards.

In Trials 061 and 071, brexpiprazole combined with sertraline demonstrated notable reductions in PTSD symptoms, with significant changes in CAPS-5 total scores compared to the placebo group. Trial 072, a fixed-dose trial, did not meet its primary endpoint, but the results were consistent with the other two trials, suggesting overall improvements in PTSD symptomatology.

The safety profile of brexpiprazole was consistent with existing data. The combination therapy was generally well-tolerated, with no new safety concerns emerging from the studies. Treatment-emergent adverse events (TEAEs) were comparable between the combination therapy and placebo groups, indicating a favorable safety margin.

Given these encouraging results, Otsuka and Lundbeck have filed a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for the use of brexpiprazole in combination with sertraline to treat PTSD in adults. This marks a significant milestone in PTSD treatment, an area that has not seen new pharmacological advancements in over two decades.

Lori Davis, M.D., a clinical professor of psychiatry at the University of Alabama School of Medicine, emphasized the importance of these findings, highlighting the potential for this combination therapy to improve the four key symptom clusters of PTSD.

John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka, pointed out the chronic nature and common misdiagnosis of PTSD, stressing that these findings represent a significant advancement in managing the disorder. Johan Luthman, Ph.D., executive vice president of research and development at Lundbeck, underscored the impact of PTSD on millions of Americans and expressed hope that this new treatment option could soon be available to those in need.

Brexpiprazole, originally approved for use in cases of major depressive disorder (MDD) and schizophrenia, has shown a high receptor binding affinity for norepinephrine, serotonin, and dopamine receptors. This makes it a potentially effective adjunctive therapy for various psychiatric conditions.

The comprehensive clinical trial program included diverse patient demographics, involving both male and female patients aged 18 to 65 years with a confirmed PTSD diagnosis. The trials involved a rigorous 1-week double-blind placebo run-in period followed by an 11-week treatment phase, ensuring robust and reliable data collection.

Overall, these findings provide a promising new direction for PTSD treatment, potentially offering a much-needed therapeutic option for millions of individuals affected by this condition. The collaboration between Otsuka and Lundbeck continues to advance the field of psychiatric treatment, aiming to address unmet medical needs with innovative therapies.

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