The studies assessed the safety and efficacy of the combination therapy in adults with post-traumatic stress disorder. Credit: Bits And Splits / Shutterstock.com.

Otsuka Pharmaceutical Development & Commercialization and Lundbeck Pharmaceuticals have reported results from three clinical trials evaluating the combination of brexpiprazole and sertraline in treating adults with post-traumatic stress disorder (PTSD).

The studies, encompassing a Phase II study (Trial 061) and two Phase III studies (Trial 071 and 072), assessed the safety and efficacy of this combination therapy.

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These trials were randomised, double-blind, and active-controlled, with Trials 061 and 071 employing a flexible dosing schedule and Trial 072 using a fixed dose schedule.

The change in the CAPS-5 total score from week one to week ten for the brexpiprazole and sertraline regimen versus sertraline plus a placebo was the primary endpoint for all three trials.

According to the findings from Trials 061 and 071, the combination regimen was associated with a statistically significant PTSD symptom reduction versus sertraline plus the placebo, meeting the primary endpoint.

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Although Trial 072 did not meet the primary endpoint, it also showed reductions in PTSD symptom severity consistent with the other two trials.

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Improvements were seen across various measures, including the Clinical Global Impression Severity (CGI-S) scale and the four CAPS-5 clusters: re-experiencing, avoidance, negative cognition/mood, and arousal/reactivity symptoms in Trials 061 and 071.

In the three trials, the brexpiprazole plus sertraline regimen was found to be well-tolerated in adult PTSD patients, without any new safety concerns detected.

The safety and tolerability data aligned with the known profile of brexpiprazole in its approved indications and other clinical trials.

The overall incidence of treatment-emergent adverse events (TEAEs) was comparable between the treatment and placebo groups.

Otsuka Pharmaceutical Development and Commercialisation executive vice-president and chief medical officer John Kraus said: “Lack of recognition and misdiagnosis of PTSD can result in ineffective management, with the average time from onset of symptoms to treatment being 12 years.

“These findings represent a remarkable advancement in managing the PTSD symptoms of those affected by this chronically misunderstood and prevalent psychiatric disorder.”

In February this year, Otsuka reported topline data from a Phase III trial of AVP-786 for treating agitation linked to dementia in Alzheimer’s disease patients.