FDA Accepts sNDA for Brexpiprazole for Adult Patients With PTSD


The supplemental new drug application (sNDA) for brexpiprazole is accepted by the FDA for treatment of patients with post-traumatic stress disorder (PTSD).

The FDA accepted the supplemental new drug application (sNDA) for brexpiprazole (Rexulti; Otsuka Pharmaceutical Co) in combination with sertraline (Zoloft; Pfizer) for treatment of adults with post-traumatic stress disorder (PTSD), potentially progressing approval efforts to offer patients advanced treatment options. The decision is based on data from 3 randomized clinical trials, which demonstrated improved tolerability and safety for patients with PTSD.

ptsd mental health treatment

Brexpiprazole’s efficacy, evidenced by the trial results, reveals its promise as an adjunctive therapy option to meet the complex needs of individuals living with PTSD. Image Credit: © Prostock-studio - stock.adobe.com

According to the National Center for PTSD, about 6 out of every 100 people will have PTSD at some point in their lives due to experiencing or witnessing a traumatic event, series of events, or set of circumstances. Common catalysts of PTSD may include emotionally or physically threatening events that have a significant impact on mental, physical, social, or spiritual well-being, often due to serious accidents, combat experience, domestic violence, or natural disasters. PTSD is categorized into 4 clusters: intrusion, avoidance, negative cognitions and mood, and marked alterations in arousal and reactivity. First-line treatment recommendations for PTSD traditionally includes psychotherapy and antidepressants, which has shown benefit for some patients over time.1,2

Brexpiprazole is an oral atypical antipsychotic agent used to treat depression and schizophrenia, as well as manage agitation in people with dementia due to Alzheimer disease, and was approved for use as an adjunctive therapy to antidepressants. The underlying mechanism of action of brexpiprazole is unknown, however study authors speculate it may involve a combination of partial agonism at serotonin 5-HT1A and dopamine D2 receptors, antagonism at serotonin 5-HT2A receptors, as well as antagonism of alpha 1B/2C receptors.2

The efficacy of brexpiprazole was investigated in 3 randomized, double blind, active-controlled trials comparing treatment with brexpiprazole and sertraline vs sertraline plus a placebo in adult patients with PTSD. Trial 061 (phase 2) and 071 (phase 3) were flexible dose trials, while trial 072 (phase 3) was a fixed-dose trial. The trials measure the difference in the Clinician-Administered PTSD Scale total score between initial randomization and week 10. All participants were diagnosed with PTSD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.2

The findings demonstrated a significant reduction (P<0.05) in PTSD symptoms in participants who received brexpiprazole in combination with sertraline in trials 061 and 071 compared with participants who received sertraline plus placebo. Additionally, the study authors identified no new safety concerns, and the tolerability results of brexpiprazole were consistent with observations made in other clinical trials. Of the participant population, 55.5% of patients receiving brexpiprazole plus sertraline experienced treatment-emergent adverse events, compared with 56.2% of patients being treated with sertraline plus placebo.2

The acceptance of brexpiprazole's sNDA for the treatment of adults with PTSD marks growing advancements in therapeutic options for patients. Brexpiprazole’s efficacy, evidenced by the trial results, reveals its promise as an adjunctive therapy option to meet the complex needs of individuals living with PTSD.

“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,” Johan Luthman, PhD, executive vice president of Lundbeck Research & Development, said in a press release. “We are grateful to the patients and caregivers who participated in these important trials.”2


  1. PTSD: national center for PTSD. US Department of Veteran Affairs. Accessed June 25, 2024. https://www.ptsd.va.gov/understand/common/common_adults.asp
  2. 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). BusinessWire. June 25, 2024. Accessed 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
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