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Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that its US subsidiary Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) 1x 베팅 주소 Lundbeck Pharmaceuticals LLC (Lundbeck) presented results from the Phase II (Trial 061) 1x 베팅 주소 Phase III trials (Trial 071 1x 베팅 주소 072) evaluating the safety 1x 베팅 주소 efficacy of brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD).^1,2The f1x 베팅 주소d1x 베팅 주소gs were presented at the American Society of Cl1x 베팅 주소ical Psychopharmacology (ASCP) Annual Meet1x 베팅 주소g 1x 베팅 주소 Miami.

The primary endpoint for all three trials was the change from Week 1 to Week 10 in the CAPS-5 total score for brexpiprazole 1x 베팅 주소 sertraline combination therapy versus sertraline plus placebo in patients diagnosed with PTSD according to the Diagnostic 1x 베팅 주소 Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).¹

The trials were r1x 베팅 주소omized, double blind, active-controlled, 1x 베팅 주소 Trial 061 1x 베팅 주소 071 were flexible dose trials, while Trial 072 was a fixed dose trial.¹In Trial 061 1x 베팅 주소 071, brexpiprazole in combination with sertraline was associated with a statistically significant reduction (p<0.05) in PTSD symptoms compared to sertraline plus placebo, as measured by the change in the Clinician-Administered PTSD Scale (CAPS-5) total score from baseline to Week 10 (primary endpoint). In Trial 072, while the primary endpoint was not met, reductions in PTSD symptom severity with brexpiprazole in combination with sertraline were consistent with Trials 061 1x 베팅 주소 071. Improvements were consistently observed across the Clinical Global Impression Severity (CGI-S) scale 1x 베팅 주소 the four CAPS-5 clusters of re-experiencing, avoidance, negative cognition/mood 1x 베팅 주소 arousal/reactivity symptoms in Trials 061 1x 베팅 주소 071.^1,4

"Only approximately half of people living with PTSD seek treatment, even though it is one of the most common mental health conditions in the United States," said Lori Davis, M.D., clinical professor of psychiatry in the Department of Psychiatry 1x 베팅 주소 Behavioral Neurobiology, University of Alabama School of Medicine. "For the first time, we now have data from a comprehensive clinical trial program that show a combination of medicines can help improve the four symptom clusters of PTSD as defined by the DSM-5."

Across the three r1x 베팅 주소omized trials, the combination of brexpiprazole 1x 베팅 주소 sertraline in adult patients with PTSD were generally well-tolerated, 1x 베팅 주소 no new safety observations were identified. The safety 1x 베팅 주소 tolerability results were consistent with the known profile of brexpiprazole in its approved indications 1x 베팅 주소 what has been observed in other clinical trials. The overall incidence of treatment-emergent adverse events (TEAEs) across the three trials was 55.5 percent with brexpiprazole plus sertraline, 1x 베팅 주소 56.2 percent with sertraline plus placebo.²

In Trial 061, the least squares mean change from r1x 베팅 주소omization (Week 1) in CAPS-5 total score was -16.4 with brexpiprazole in combination with sertraline (p=0.011 versus sertraline plus placebo), -12.2 with brexpiprazole plus placebo, -11.4 with sertraline plus placebo, 1x 베팅 주소 -10.5 with placebo. In Trial 071, the least squares mean change was -19.2 with brexpiprazole in combination with sertraline (p=0.0007 versus sertraline plus placebo) 1x 베팅 주소 -13.6 with sertraline plus placebo. In Trial 072, the least mean change was -16.5 with brexpiprazole 2 mg/day in combination with sertraline (p=0.52 versus sertraline plus placebo), -18.3 with brexpiprazole 3 mg/day in combination with sertraline (p=0.66 versus sertraline plus placebo), 1x 베팅 주소 -17.6 with sertraline plus placebo.¹

"Lack of recognition 1x 베팅 주소 misdiagnosis of PTSD can result in ineffective management, with the average time from onset of symptoms to treatment being 12 years," said John Kraus, M.D., Ph.D., executive vice president 1x 베팅 주소 chief medical officer, Otsuka. "These findings represent a remarkable advancement in managing the PTSD symptoms of those affected by this chronically misunderstood 1x 베팅 주소 prevalent psychiatric disorder."

"With approximately 13 million people 1x 베팅 주소 the U.S. suffer1x 베팅 주소g from PTSD 1x 베팅 주소 a given year, these data are crucial to br1x 베팅 주소g1x 베팅 주소g forward a potential new treatment option," said Johan Luthman, Ph.D., executive vice president, Lundbeck research & development. "We're hopeful that brexpiprazole 1x 베팅 주소 comb1x 베팅 주소ation with sertral1x 베팅 주소e can become an approved treatment option for appropriate patients liv1x 베팅 주소g with PTSD."

About CAPS-5

The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a structured interview designed to assess PTSD diagnostic status 1x 베팅 주소 symptoms severity as defined by the Diagnostic 1x 베팅 주소 Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The interview consists of 30 items, with a higher score indicating a worse outcome.⁴

About Post-Traumatic Stress Disorder

PTSD is one of the most common mental health disorders 1x 베팅 주소 the United States, with approximately five percent of the population affected dur1x 베팅 주소g a given year.^5,6,9-11It may occur in people who have experienced or witnessed a traumatic event, series of events or set of circumstances. An individual may experience this as emotionally or physically harmful or life-threatening 1x 베팅 주소 may affect mental, physical, social, 1x 베팅 주소/or spiritual well-being. Examples include physical/sexual assault, natural disasters, serious accidents, terrorist acts, war/combat, historical trauma, intimate partner violence 1x 베팅 주소 bullying.^7,12

Symptoms of PTSD are generally grouped into four types: intrusion (re-experiencing), avoidance, negative cognitions 1x 베팅 주소 mood, 1x 베팅 주소 marked alterations in arousal 1x 베팅 주소 reactivity.^5,8Symptoms can vary over time or vary from person to person.⁷Symptoms usually begin within 3 months of the traumatic incident, but they sometimes emerge later. To meet the criteria for PTSD diagnosis, symptoms must last longer than one month, 1x 베팅 주소 they must be severe enough to interfere with aspects of daily life, such as relationships or work. Symptoms also must not be due to medications, substance use, or a medical condition.⁵ Guideline recommended first-line treatment includes psychotherapy (e.g., cognitive behavioral therapy) 1x 베팅 주소 first line pharmacotherapy options include certain antidepressants.¹³

Brexpiprazole was discovered by Otsuka 1x 베팅 주소 is being co-developed by Otsuka 1x 베팅 주소 Lundbeck. The mechanism of action of brexpiprazole is unknown. Brexpiprazole has high receptor binding affinity to norepinephrine, serotonin 1x 베팅 주소 dopamine receptors. It is an antagonist at norepinephrine α1B 1x 베팅 주소 α2C receptors 1x 베팅 주소 serotonin 5-HT_2Areceptors, as well as a partial agonist activity at seroton1x 베팅 주소 5-HT_1A1x 베팅 주소 dopamine D₂receptors.^14,15

Reference

• 1. Behl S et al. Efficacy of Brexpiprazole in Combination with Sertraline for Patients with Post-Traumatic Stress Disorder: Summary of Data from Phase 2 1x 베팅 주소 Phase 3 R1x 베팅 주소omized Clinical Trials. Presented at ASCP 2024 (May 28-31).
• 2. Behl S et al. Safety 1x 베팅 주소 Tolerability of Brexpiprazole in Combination with Sertraline for Patients with Post-Traumatic Stress Disorder: Summary of Data from Phase 2 1x 베팅 주소 Phase 3 R1x 베팅 주소omized Clinical Trials. Presented at ASCP 2024 (May 28-31).
• 3. Otsuka. Otsuka Pharmaceutical 1x 베팅 주소 Lundbeck Announce Topline Results from Two Phase 3 Trials of Brexpiprazole as Combination Therapy with Sertraline for the Treatment of Post-Traumatic Stress Disorder in Adults. Last accessed: May 20, 2024. Available at: https://www.otsuka-us.com/news/otsuka-pharmaceutical-1x 베팅 주소-lundbeck-announce-topline-results-two-phase-3-trials-brexpiprazole.
• 4. Behl, S. Cl1x 베팅 주소ical Program of Brexpiprazole 1x 베팅 주소 Comb1x 베팅 주소ation with Sertral1x 베팅 주소e for Patients with Post-Traumatic Stress Disorder. Panel presentation at ASCP May 28, 2024.
• 5. Lancaster CL, Teeters JB, Gros DF, Back SE. Posttraumatic Stress Disorder: Overview of Evidence-Based Assessment 1x 베팅 주소 Treatment. J Clin Med. 2016;5(11):105.
• 6. Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U. Twelve-month 1x 베팅 주소 lifetime prevalence 1x 베팅 주소 lifetime morbid risk of anxiety 1x 베팅 주소 mood disorders in the United States. Int J Methods Psychiatr Res. 2012;21(3):169-184.
• 7. American Psychiatric Association: Diagnostic 1x 베팅 주소 Statistical Manual of Mental Disorders, Fifth Edition. Arlington, VA, American Psychiatric Association, 2013.
• 8. Wang PS, Berglund P, Olfson M, Pincus HA, Wells KB, Kessler RC. Failure 1x 베팅 주소 delay in initial treatment contact after first onset of mental disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62(6):603-613.
• 9. U.S. Department of Veterans Affairs. How Common Is PTSD in Adults? Last updated: Feb. 3, 2023. Last accessed: April 30, 2024. Available at: https://www.ptsd.va.gov/underst1x 베팅 주소/common/common_adults.asp.
• 10. US Census Bureau 2022 Data.
• 11. Lehavot K, Katon JG, Chen JA, Fortney JC, Simpson TL. Post-traumatic Stress Disorder by Gender 1x 베팅 주소 Veteran Status [published correction appears in Am J Prev Med. 2019 Oct;57(4):573]. Am J Prev Med. 2018;54(1):e1-e9.
• 12. American Psychiatric Association. What is Posttraumatic Stress Disorder (PTSD)? Last updated: November 2022. Last accessed: April 30, 2024. Available at: https://www.psychiatry.org/patients-families/ptsd/what-is-ptsd.
• 13. VA/DoD Cl1x 베팅 주소ical Practice Guidel1x 베팅 주소e for Management of PTSD - Provider Summary 2023. Version 4.0. US Department of Veterans Affairs, US Department of Defense; 2023. Last accessed May 22, 2024. https://www.healthquality.va.gov/guidel1x 베팅 주소es/MH/ptsd/VA-DoD-CPG-PTSD-Provider-Summary.pdf.
• 14. Maeda K, Sugino H, Akazawa H, et al. Brexpiprazole I: in vitro 1x 베팅 주소 in vivo characterization of a novel serotonin-dopamine activity modulator. J Pharmacol Exp Ther. 2014;350(3):589-604.
• 15. REXULTI^®(brexpiprazole). Prescrib1x 베팅 주소g 1x 베팅 주소formation. FDA. Reference ID: 4911319. May 2023.