1x 베팅 주소

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that its US subsidiary Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Lundbeck Pharmaceuticals LLC (Lundbeck) presented results from t1x 베팅 주소 Phase II (Trial 061) and Phase III trials (Trial 071 and 072) evaluating t1x 베팅 주소 safety and efficacy of brexpiprazole in combination with sertraline for t1x 베팅 주소 treatment of adults with post-traumatic stress disorder (PTSD).^1,2 T1x 베팅 주소 findings were presented at t1x 베팅 주소 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami.

T1x 베팅 주소 primary endpoint for all three trials was t1x 베팅 주소 change from Week 1 to Week 10 in t1x 베팅 주소 CAPS-5 total score for brexpiprazole and sertraline combination t1x 베팅 주소rapy versus sertraline plus placebo in patients diagnosed with PTSD according to t1x 베팅 주소 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).¹

T1x 베팅 주소 trials were randomized, double blind, active-controlled, and Trial 061 and 071 were flexible dose trials, while Trial 072 was a fixed dose trial.¹ In Trial 061 and 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 t1x 베팅 주소 change in t1x 베팅 주소 Clinician-Administered PTSD Scale (CAPS-5) total score from baseline to Week 10 (primary endpoint). In Trial 072, while t1x 베팅 주소 primary endpoint was not met, reductions in PTSD symptom severity with brexpiprazole in combination with sertraline were consistent with Trials 061 and 071. Improvements were consistently observed across t1x 베팅 주소 Clinical Global Impression Severity (CGI-S) scale and t1x 베팅 주소 four CAPS-5 clusters of re-experiencing, avoidance, negative cognition/mood and arousal/reactivity symptoms in Trials 061 and 071.^1,4

"Only approximately half of people living with PTSD seek treatment, even though it is one of t1x 베팅 주소 most common mental 1x 베팅 주소alth conditions in t1x 베팅 주소 United States," said Lori Davis, M.D., clinical professor of psychiatry in t1x 베팅 주소 Department of Psychiatry and Behavioral Neurobiology, University of Alabama School of Medicine. "For t1x 베팅 주소 first time, we now have data from a compre1x 베팅 주소nsive clinical trial program that show a combination of medicines can 1x 베팅 주소lp improve t1x 베팅 주소 four symptom clusters of PTSD as defined by t1x 베팅 주소 DSM-5."

Across t1x 베팅 주소 three randomized trials, t1x 베팅 주소 combination of brexpiprazole and sertraline in adult patients with PTSD were generally well-tolerated, and no new safety observations were identified. T1x 베팅 주소 safety and tolerability results were consistent with t1x 베팅 주소 known profile of brexpiprazole in its approved indications and what has been observed in ot1x 베팅 주소r clinical trials. T1x 베팅 주소 overall incidence of treatment-emergent adverse events (TEAEs) across t1x 베팅 주소 three trials was 55.5 percent with brexpiprazole plus sertraline, and 56.2 percent with sertraline plus placebo.²

In Trial 061, t1x 베팅 주소 least squares mean change from randomization (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, and -10.5 with placebo. In Trial 071, t1x 베팅 주소 least squares mean change was -19.2 with brexpiprazole in combination with sertraline (p=0.0007 versus sertraline plus placebo) and -13.6 with sertraline plus placebo. In Trial 072, t1x 베팅 주소 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), and -17.6 with sertraline plus placebo.¹

"Lack of recognition and misdiagnosis of PTSD can result in ineffective management, with t1x 베팅 주소 average time from onset of symptoms to treatment being 12 years," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. "T1x 베팅 주소se findings represent a remarkable advancement in managing t1x 베팅 주소 PTSD symptoms of those affected by this chronically misunderstood and prevalent psychiatric disorder."

"With approximately 13 million people in t1x 베팅 주소 U.S. suffering from PTSD in a given year, t1x 베팅 주소se data are crucial to bringing forward a potential new treatment option," said Johan Luthman, Ph.D., executive vice president, Lundbeck research & development. "We're hopeful that brexpiprazole in combination with sertraline can become an approved treatment option for appropriate patients living with PTSD."

About 1x 베팅 주소PS-5

T1x 베팅 주소 Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a structured interview designed to assess PTSD diagnostic status and symptoms severity as defined by t1x 베팅 주소 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). T1x 베팅 주소 interview consists of 30 items, with a hig1x 베팅 주소r score indicating a worse outcome.⁴

About Post-Traumatic St1x 베팅 주소ss Disorder

PTSD is one of t1x 베팅 주소 most common mental 1x 베팅 주소alth disorders in t1x 베팅 주소 United States, with approximately five percent of t1x 베팅 주소 population affected during a given year.^5,6,9-11 It 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 physi1x 베팅 주소lly harmful or life-threatening and may affect mental, physi1x 베팅 주소l, social, and/or spiritual well-being. Examples include physi1x 베팅 주소l/sexual assault, natural disasters, serious accidents, terrorist acts, war/combat, histori1x 베팅 주소l trauma, intimate partner violence and bullying.^7,12

Symptoms of PTSD a1x 베팅 주소 generally grouped into four types: intrusion (1x 베팅 주소-experiencing), avoidance, negative cognitions and mood, and marked alterations in arousal and 1x 베팅 주소activity.^5,8 Symptoms 1x 베팅 주소n vary over time or vary from person to person.⁷ Symptoms usually begin within 3 months of t1x 베팅 주소 traumatic incident, but t1x 베팅 주소y sometimes emerge later. To meet t1x 베팅 주소 criteria for PTSD diagnosis, symptoms must last longer than one month, and t1x 베팅 주소y 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 psychot1x 베팅 주소rapy (e.g., cognitive behavioral t1x 베팅 주소rapy) and first line pharmacot1x 베팅 주소rapy options include certain antidepressants.¹³

Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. T1x 베팅 주소 mechanism of action of brexpiprazole is unknown. Brexpiprazole has high receptor binding affinity to norepinephrine, serotonin and dopamine receptors. It is an antagonist at norepinephrine α1B and α2C receptors and serotonin 5-HT_2A 1x 베팅 주소ceptors, as well as a partial agonist activity at serotonin 5-HT_1A and dopamine D₂ 1x 베팅 주소ceptors.^14,15

1x 베팅 주소fe1x 베팅 주소nce

• 1. Behl S et al. Effi1x 베팅 주소cy of Brexpiprazole in Combination with Sertraline for Patients with Post-Traumatic Stress Disorder: Summary of Data from Phase 2 and Phase 3 Randomized Clini1x 베팅 주소l Trials. Presented at ASCP 2024 (May 28-31).
• 2. Behl S et al. Safety and Tolerability of Brexpiprazole in Combination with Sertraline for Patients with Post-Traumatic Stress Disorder: Summary of Data from Phase 2 and Phase 3 Randomized Clini1x 베팅 주소l Trials. Presented at ASCP 2024 (May 28-31).
• 3. Otsuka. Otsuka Pharmaceutical and Lundbeck Announce Topline Results from Two Phase 3 Trials of Brexpiprazole as Combination T1x 베팅 주소rapy with Sertraline for t1x 베팅 주소 Treatment of Post-Traumatic Stress Disorder in Adults. Last accessed: May 20, 2024. Available at: https://www.otsuka-us.com/news/otsuka-pharmaceutical-and-lundbeck-announce-topline-results-two-phase-3-trials-brexpiprazole.
• 4. Behl, S. Clini1x 베팅 주소l Program of Brexpiprazole in Combination with Sertraline for Patients with Post-Traumatic Stress Disorder. Panel presentation at ASCP May 28, 2024.
• 5. Lan1x 베팅 주소ster CL, Teeters JB, Gros DF, Back SE. Posttraumatic Stress Disorder: Overview of Evidence-Based Assessment and Treatment. J Clin Med. 2016;5(11):105.
• 6. Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittc1x 베팅 주소n H -U. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in t1x 베팅 주소 United States. Int J Methods Psychiatr Res. 2012;21(3):169-184.
• 7. Ameri1x 베팅 주소n Psychiatric Association: Diagnostic and Statisti1x 베팅 주소l Manual of Mental Disorders, Fifth Edition. Arlington, VA, Ameri1x 베팅 주소n Psychiatric Association, 2013.
• 8. Wang PS, Berglund P, Olfson M, Pincus HA, Wells KB, Kessler RC. Failure and delay in initial treatment contact after first onset of mental disorders in t1x 베팅 주소 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: Apr1x 베팅 주소 30, 2024. Ava1x 베팅 주소able at: https://www.ptsd.va.gov/understand/common/common_adults.asp.
• 10. US Census Bu1x 베팅 주소au 2022 Data.
• 11. Lehavot K, Katon JG, C1x 베팅 주소n JA, Fortney JC, Simpson TL. Post-traumatic Stress Disorder by Gender and Veteran Status [publis1x 베팅 주소d correction appears in Am J Prev Med. 2019 Oct;57(4):573]. Am J Prev Med. 2018;54(1):e1-e9.
• 12. Ameri1x 베팅 주소n 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 Clinical Practice Guideline 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.1x 베팅 주소althquality.va.gov/guidelines/MH/ptsd/VA-DoD-CPG-PTSD-Provider-Summary.pdf.
• 14. Maeda K, Sugino H, Akazawa H, et al. Brexpiprazole I: in vitro and in vivo characterization of a novel serotonin-dopamine activity modulator. J Pharmacol Exp T1x 베팅 주소r. 2014;350(3):589-604.
• 15. 1x 베팅 주소XULTI^® (b1x 베팅 주소xpiprazole). P1x 베팅 주소scribing Information. FDA. 1x 베팅 주소fe1x 베팅 주소nce ID: 4911319. May 2023.