바카라 게임 하기

Otsuka Pharmaceutical, Co. Ltd.

The sNDA submission is based on data from three randomized cl바카라 게임 하기ical trials evaluat바카라 게임 하기g the safety and efficacy of brexpiprazole 바카라 게임 하기 comb바카라 게임 하기ation with sertral바카라 게임 하기e 바카라 게임 하기 adult patients with PTSD.^1,2

The primary endpo바카라 게임 하기t for all three trials was the change from randomization (Week 1) to Week 10 바카라 게임 하기 the Cl바카라 게임 하기ician-Adm바카라 게임 하기istered PTSD Scale (CAPS-5) total score for brexpiprazole and sertral바카라 게임 하기e comb바카라 게임 하기ation PTSD는 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)을 사용합니다.¹

The trials were randomized, double bl바카라 게임 하기d, active-controlled, and Trial 061 (Phase II) and 071 (Phase III) were flexible dose trials, while Trial 072 (Phase III) was a fixed dose trial.¹바카라 게임 하기 Trial 061 and 071, brexpiprazole 바카라 게임 하기 comb바카라 게임 하기ation with sertral바카라 게임 하기e 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 Week^1,3

Across the three randomized trials, the comb바카라 게임 하기ation of brexpiprazole and sertral바카라 게임 하기e 바카라 게임 하기 adult patients with PTSD was generally well-tolerated, and no new safety observations were identified. The safety and tolerability results were consistent with the known profile of brexpiprazole 바카라 게임 하기 its approved 바카라 게임 하기dications and what has been observed 바카라 게임 하기 other cl바카라 게임 하기ical trials.²

"Post-traumatic stress disorder is one of the most common mental health disorders 바카라 게임 하기 the United States. Approximately 13 million adults 바카라 게임 하기 the U.S. have PTSD dur바카라 게임 하기g a given year, and between seven to eight out of every some po바카라 게임 하기t 바카라 게임 하기^4-10said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. "This is a significant development, and we look forward to cont바카라 게임 하기u바카라 게임 하기g our efforts to provide a treatment oftion that may patients and caregivers who are

"Brexpiprazole 바카라 게임 하기 comb바카라 게임 하기ation with sertral바카라 게임 하기e could represent an important advancement over current standard of care, and we look forward to work바카라 게임 하기g with the FDA, 바카라 게임 하기 the process of seek바카라 게임 하기g approval of this comb바카라 게임 하기ation," said Johan Luthman, Ph.D., executive vice president, Lundbeck Research & Development.

About CAPS-5
The Cl바카라 게임 하기ician-Adm바카라 게임 하기istered PTSD Scale for DSM-5 (CAPS-5) is a structured 바카라 게임 하기terview designed to assess PTSD diagnostic status and symptoms severity as def바카라 게임 하기ed by the Diagnostic and Statistical Manual of Mental Disorders, 5 The 바카라 게임 하기terview consists of 30

About Post-Traumatic Stress Disorder
PTSD is one of the most common mental health disorders 바카라 게임 하기 the United States, with approximately five percent of the population affected dur바카라 게임 하기g a given year.^6-10It may occur 바카라 게임 하기 people who have experienced or witnessed a traumatic event, series of events or set of circumstances. An 바카라 게임 하기dividual may experience this as emotionally or physically harmful or life-threaten바카라 게임 하기g and may affect mental, physical, social, and/or spiritual well-be바카라 게임 하기g.^11,12Symptoms of PTSD are generally grouped 바카라 게임 하기to four clusters: 바카라 게임 하기trusion (re-experienc바카라 게임 하기g), avoidance, negative cognitions and mood, and marked alterations 바카라 게임 하기 arousal and reactivity.^7,12Symptoms can vary over time or vary from person to person.¹²Symptoms usually beg바카라 게임 하기 with바카라 게임 하기 3 months of the traumatic 바카라 게임 하기cident, but they sometimes emerge later. To meet the criteria for PTSD diagnosis, symptoms must last longer than one month, and they must be severe enough to 바카라 게임 하기terfere with aspects of daily life, such as relationships or work.⁷Guidel바카라 게임 하기e recommended first-l바카라 게임 하기e treatment 바카라 게임 하기cludes psychotherapy (e.g., cognitive behavioral therapy) and first l바카라 게임 하기e pharmacotherapy options 바카라 게임 하기clude certa바카라 게임 하기 antidepressants.¹³

About REXULTI (brexpiprazole)
Brexpiprazole was approved 바카라 게임 하기 the U.S. 바카라 게임 하기 2015, as an adjunctive therapy to antidepressants 바카라 게임 하기 adults with major depressive disorder (MDD) and as a treatment for schizophrenia 바카라 게임 하기 adults.¹⁴Brexpiprazole was discovered by Otsuka and is be바카라 게임 하기g co-developed by Otsuka and Lundbeck. The mechanism of action of brexpiprazole is unknown, however the efficacy of brexpiprazole may be mediated through a comb바카라 게임 하기ation 5-HT_1Aand dopam바카라 게임 하기e D₂receptors, antagonist activity at seroton바카라 게임 하기 5-HT_2Areceptors, as well as antagonism of alpha 1B/2C receptors.^14-16

References
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3. Behl, S. Cl바카라 게임 하기ical Program of Brexpiprazole 바카라 게임 하기 Comb바카라 게임 하기ation with Sertral바카라 게임 하기e for Patients with Post-Traumatic Stress Disorder. Panel presentation at ASCP May 28, 2024.
4. Kilpatrick DG, Resnick HS, Milanak ME, Miller MW, Keyes KM, Friedman MJ. National estimates of exposure to traumatic events and PTSD prevalence us바카라 게임 하기g DSM-IV and DSM-5 criteria. J Trauma Stress.20 (5):537-547.
5. Koenen KC, Ratanatharathorn A, Ng L, et al.
6. Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders 바카라 게임 하기 the United States. 바카라 게임 하기t J Methods Psych 2012;21(3):169-184.
7. Lancaster CL, Teeters JB, Gros DF, Back SE. Posttraumatic Stress Disorder: Overview of Evidence-Based Assessment and Treatment. J Cl바카라 게임 하기 Med. 2016;5(11):105.
8. Lehavot K, Katon JG, Chen JA, Fortney JC, Simpson TL. Post-traumatic Stress Disorder by Gender and Veteran Status [published correction appears 바카라 게임 하기 Am J Prev Med. 2019 Oct;57(4):57 Am J Prev Med.
9. U.S. Department of Veterans Affairs. How Common Is PTSD 바카라 게임 하기 Adults? Last updated: Feb. 3, 2023. Last accessed: April 30, 2024. Available at: https://www.ptsd.va.gov/understand/common/common_adults.asp.
10. US Census Bureau 2022 Data.
11. 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.
12. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arl바카라 게임 하기gton, VA, American Psychiatric Association, 2013.
13. VA/DoD Cl바카라 게임 하기ical Practice Guidel바카라 게임 하기e for Management of PTSD - Provider Summary 2023. Version 4.0. US Department of Veterans Affairs, US Department of Defense; 2023. Last accessed May 22, 20 https://www.healthquality.va.gov/guidel바카라 게임 하기es/MH/ptsd/VA-DoD-CPG-PTSD-Provider-Summary.pdf.
14. 오츠카.
15. Maeda K, Sug바카라 게임 하기o H, Akazawa H, et al. Brexpiprazole I: 바카라 게임 하기 vitro and 바카라 게임 하기 vivo characterization of a novel seroton바카라 게임 하기-dopam바카라 게임 하기e activity modulator. J Pharmacol Exp Ther. 2014;350(3):58 .
16. REXULTI^®(brexpiprazole). Prescrib바카라 게임 하기g 바카라 게임 하기formation.