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FDA Accepts Otsuka and Lundbeck’s Supplemental New Drug Application for Brexpiprazole to Treat Adults with Post-Traumatic Stress Disorder


Results from three randomized clinical trials show safety and efficacy of a brexpiprazole-sertraline combination in adult patients with post-traumatic stress disorder.

Silhouette of a woman in despair, symbolizing mental anguish and PTSD, against a dim background. Image Credit: Adobe Stock Images/Your Hand Please

Image Credit: Adobe Stock Images/Your Hand Please

The FDA has accepted Otsuka and Lunbdeck’s supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). 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 PTSD.1

“[PTSD] is one of the most common mental health disorders in the United States. Approximately 13 million adults in the US have PTSD during a given year, and between seven to eight out of every 100 will experience PTSD at some point in their lives,” said John Kraus, MD, PhD, EVP, chief medical officer, Otsuka, in a press release. “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.”

All three trials were randomized, double blind, and active-controlled, with trials 061 (Phase II) and 071 (Phase III) being flexible-dose trials, and trial 072 (Phase III) being a fixed-dose trial. The primary endpoint of all three trials was a change from week one to 10 in the Clinician-Administered PTSD Scale total score, which was designed to assess PTSD diagnostic status and symptom severity as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. Despite trial 072 not meeting the primary endpoint, results showed consistent reductions in PTSD symptoms. Trials 061 and 071 met the primary endpoint and demonstrated a statistically significant reduction in PTSD symptoms compared to sertraline plus placebo.

Across all three trials, the combination of brexpiprazole and sertraline was generally well-tolerated, with no new safety signals reported. Incidence of treatment-emergent adverse events (TEAEs) was 55.5% for the brexpiprazole plus sertraline group and 56.2% for the sertraline plus placebo group.1

The Mayo Clinic suggests that a number of psychotherapies, such as cognitive therapy, exposure therapy, and eye movement desensitization and reprocessing can be effective in treating PTSD. Additionally, antidepressants and anti-anxiety medications can help relieve a number of symptoms. Some studies also suggest that prazosin could potentially help reduce symptoms of PTSD; however, one study found no benefit over treatment with a placebo.2

According to the Cleveland Clinic, PTSD can develop in anywhere from 5% to 10% of people who have experienced some form of trauma. Women are more likely to experience PTSD in their lifetime than men.3

“The prognosis (outlook) for PTSD can vary, but treatment often helps. With treatment, about 30% of people eventually recover from the condition,” reports the Cleveland Clinic. “About 40% of people get better with treatment, but mild to moderate symptoms may remain. For some people, symptoms of PTSD go away over time with the support of loved ones and without professional treatment.”

Studies suggest that there are ways to prevent PTSD from manifesting, including support groups, healthy coping strategies, helping others, and seeking support from loved ones.3

“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, EVP, Lundbeck Research & Development, in the press release. “We are grateful to the patients and caregivers who participated in these important trials.”

The FDA assigned the application with a Prescription Drug User Fee Act (PDUFA) target action date of February 8, 2025.1


1. 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). Lundbeck. June 25, 2024. Accessed June 26, 2024. https://www.newsroom.lundbeckus.com/news-release/2024/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

2. Post-traumatic stress disorder (PTSD). Mayo Clinic. Accessed June 26, 2024. https://www.mayoclinic.org/diseases-conditions/post-traumatic-stress-disorder/diagnosis-treatment/drc-20355973

3. PTSD (Post-Traumatic Stress Disorder). Cleveland Clinic. Accessed June 26, 2024. https://my.clevelandclinic.org/health/diseases/9545-post-traumatic-stress-disorder-ptsd

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