Saturday, July 13, 2024

Post-Traumatic Stress Disorder Treatment Advanced as FDA Accepts Otsuka and Lundbeck’s sNDA for Brexpiprazole

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Post-traumatic stress disorder (PTSD) treatment advances as the Food and Drug Administration (FDA) accepts Otsuka and Lundbeck’s supplemental New Drug Application (sNDA) for the Brexpiprazole and Sertraline combination. This acceptance marks a significant milestone in the development of new treatment options for PTSD, a condition that affects millions of individuals worldwide. The sNDA is supported by data from three randomized clinical trials that evaluated the safety and efficacy of the brexpiprazole-sertraline combination in adult patients with post-traumatic stress disorder.

The three pivotal trials—061 (Phase II), 071 (Phase III), and 072 (Phase III)—were designed to rigorously assess the potential benefits of the brexpiprazole-sertraline combination. These trials were randomized, double-blind, and active-controlled, ensuring robust and reliable results. Trials 061 and 071 were flexible-dose studies, while trial 072 was a fixed-dose study.

The primary endpoint for all three trials was the change in the Clinician-Administered PTSD Scale (CAPS) total score from week one to week ten. This scale is a standardized measure used to assess post-traumatic stress disorder diagnostic status and symptom severity, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). While trial 072 did not meet its primary endpoint, it still showed consistent reductions in PTSD symptoms. Importantly, trials 061 and 071 met the primary endpoint, demonstrating statistically significant reductions in PTSD symptoms compared to the sertraline plus placebo group.

Brexpiprazole-Sertraline Combo Shows Promise for Post-Traumatic Stress Disorder

Safety is a crucial aspect of any new treatment, and the brexpiprazole-sertraline combination was generally well-tolerated across all three trials. No new safety signals were reported, and the incidence of treatment-emergent adverse events (TEAEs) was comparable between the brexpiprazole plus sertraline group (55.5%) and the sertraline plus placebo group (56.2%).

PTSD is one of the most common mental health disorders in the United States, affecting approximately 13 million adults annually. Between seven to eight out of every 100 people will experience post-traumatic stress disorder at some point in their lives. “This is a significant development, and we look forward to continuing our efforts to provide a treatment option that may benefit the millions of patients and caregivers who are impacted by the debilitating effects of PTSD,” said John Kraus, MD, PhD, EVP, Chief Medical Officer at Otsuka.

The Mayo Clinic highlights several effective psychotherapies for PTSD, including cognitive therapy, exposure therapy, and eye movement desensitization and reprocessing (EMDR). Antidepressants and anti-anxiety medications can also help relieve post-traumatic stress disorder symptoms. However, there is a continuous need for new treatments as current options do not work for everyone. For instance, while some studies suggest that prazosin might help reduce PTSD symptoms, other studies, including one notable study, found no benefit over placebo treatment.

Post-Traumatic Stress Disorder

Cleveland Clinic Highlights Post-Traumatic Stress Disorder Risks and Treatment

According to the Cleveland Clinic, PTSD can develop in 5% to 10% of people who experience trauma, with women being more likely than men to develop the condition. Treatment outcomes vary, but with appropriate intervention, about 30% of individuals eventually recover fully, while around 40% experience significant improvement, although some symptoms may persist. Preventing PTSD involves several strategies, such as engaging in support groups, developing healthy coping mechanisms, helping others, and seeking support from loved ones. These measures can mitigate the impact of traumatic experiences and reduce the likelihood of developing post-traumatic stress disorder.

“Brexpiprazole in combination with sertraline could represent an important advancement over the 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, EVP, Lundbeck Research & Development. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 8, 2025, for the review of this application.

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The acceptance of this sNDA by the FDA signifies a hopeful advancement in the treatment of post-traumatic stress disorder. If approved, the brexpiprazole-sertraline combination could provide a new therapeutic option for the millions of individuals affected by this debilitating condition, offering hope for better management and improved quality of life.

 

Resource: News Room, June 26, 2024

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