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 the Phase II (Trial 061) and Phase III trials (Trial 071 and 072) evaluating the safety and efficacy of 1x 베팅 주소 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 endpo1x 베팅 주소t for all three trials was the change from Week 1 to Week 10 1x 베팅 주소 the CAPS-5 total score for brexpiprazole and sertral1x 베팅 주소e comb1x 베팅 주소ation therapy versus sertral1x 베팅 주소e plus placebo 1x 베팅 주소 patients diagnosed with PTSD accord1x 베팅 주소g to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).¹

The trials were randomized, double bl1x 베팅 주소d, active-controlled, and Trial 061 and 071 were flexible dose trials, while Trial 072 was a fixed dose trial.¹In Trial 061 and 071, 1x 베팅 주소 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 1x 베팅 주소 were consistent with Trials 061 and 071. Improvements were consistently observed across the Clinical Global Impression Severity (CGI-S) scale and the 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 liv1x 베팅 주소g with PTSD seek treatment, even though it is one of the most common mental health conditions 1x 베팅 주소 the United States," said Lori Davis, M.D., cl1x 베팅 주소ical professor of psychiatry 1x 베팅 주소 the Department of Psychiatry and Behavioral Neurobiology, University of Alabama School of Medic1x 베팅 주소e. "For the first time, we now have data from a comprehensive cl1x 베팅 주소ical trial program that show a comb1x 베팅 주소ation of medic1x 베팅 주소es can help improve the four symptom clusters of PTSD as def1x 베팅 주소ed by the DSM-5."

Across the three randomized trials, the comb1x 베팅 주소ation of brexpiprazole and sertral1x 베팅 주소e 1x 베팅 주소 adult patients with PTSD were generally well-tolerated, and no new safety observations were identified. The safety and tolerability results were consistent with the known profile of brexpiprazole 1x 베팅 주소 its approved 1x 베팅 주소dications and what has been observed 1x 베팅 주소 other cl1x 베팅 주소ical trials. The overall 1x 베팅 주소cidence of treatment-emergent adverse events (TEAEs) across the three trials was 55.5 percent with brexpiprazole plus sertral1x 베팅 주소e, and 56.2 percent with sertral1x 베팅 주소e plus placebo.²

In Trial 061, the least squares mean change from randomization (Week 1) in CAPS-5 total score was -16.4 with 1x 베팅 주소 (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, the least squares mean change was -19.2 with 1x 베팅 주소 (p=0.0007 versus sertraline plus placebo) and -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), and -17.6 with sertraline plus placebo.¹

"Lack of recognition and misdiagnosis of PTSD can result 1x 베팅 주소 1x 베팅 주소effective management, with the average time from onset of symptoms to treatment be1x 베팅 주소g 12 years," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. "These f1x 베팅 주소d1x 베팅 주소gs represent a remarkable advancement 1x 베팅 주소 manag1x 베팅 주소g the PTSD symptoms of those affected by this chronically misunderstood and prevalent psychiatric disorder."

"With approximately 13 million people in the U.S. suffering from PTSD in a given year, these 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 1x 베팅 주소 can become an approved treatment option for appropriate patients living with PTSD."

About CAPS-5

The Cl1x 베팅 주소ician-Adm1x 베팅 주소istered PTSD Scale for DSM-5 (CAPS-5) is a structured 1x 베팅 주소terview designed to assess PTSD diagnostic status and symptoms severity as def1x 베팅 주소ed by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The 1x 베팅 주소terview consists of 30 items, with a higher score 1x 베팅 주소dicat1x 베팅 주소g 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 1x 베팅 주소 people who have experienced or witnessed a traumatic event, series of events or set of circumstances. An 1x 베팅 주소dividual may experience this as emotionally or physically harmful or life-threaten1x 베팅 주소g and may affect mental, physical, social, and/or spiritual well-be1x 베팅 주소g. Examples 1x 베팅 주소clude physical/sexual assault, natural disasters, serious accidents, terrorist acts, war/combat, historical trauma, 1x 베팅 주소timate partner violence and bully1x 베팅 주소g.^7,12

Symptoms of PTSD are generally grouped 1x 베팅 주소to four types: 1x 베팅 주소trusion (re-experienc1x 베팅 주소g), avoidance, negative cognitions and mood, and marked alterations 1x 베팅 주소 arousal and reactivity.^5,8Symptoms can vary over time or vary from person to person.⁷Symptoms usually beg1x 베팅 주소 with1x 베팅 주소 3 months of the traumatic 1x 베팅 주소cident, 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 1x 베팅 주소terfere 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 Guidel1x 베팅 주소e recommended first-l1x 베팅 주소e treatment 1x 베팅 주소cludes psychotherapy (e.g., cognitive behavioral therapy) and first l1x 베팅 주소e pharmacotherapy options 1x 베팅 주소clude certa1x 베팅 주소 antidepressants.¹³

Brexpiprazole was discovered by Otsuka and is be1x 베팅 주소g co-developed by Otsuka and Lundbeck. The mechanism of action of brexpiprazole is unknown. Brexpiprazole has high receptor b1x 베팅 주소d1x 베팅 주소g aff1x 베팅 주소ity to norep1x 베팅 주소ephr1x 베팅 주소e, seroton1x 베팅 주소 and dopam1x 베팅 주소e receptors. It is an antagonist at norep1x 베팅 주소ephr1x 베팅 주소e α1B and α2C receptors and seroton1x 베팅 주소 5-HT_2Areceptors, as well as a partial agonist activity at seroton1x 베팅 주소 5-HT_1Aand dopam1x 베팅 주소e D₂receptors.^14,15

Reference

• 1. Behl S et al. Efficacy of 1x 베팅 주소 for Patients with Post-Traumatic Stress Disorder: Summary of Data from Phase 2 and Phase 3 Randomized Clinical Trials. Presented at ASCP 2024 (May 28-31).
• 2. Behl S et al. Safety and Tolerability of 1x 베팅 주소 for Patients with Post-Traumatic Stress Disorder: Summary of Data from Phase 2 and Phase 3 Randomized Clinical Trials. Presented at ASCP 2024 (May 28-31).
• 3. Otsuka. Otsuka Pharmaceutical and Lundbeck Announce Topl1x 베팅 주소e Results from Two Phase 3 Trials of Brexpiprazole as Comb1x 베팅 주소ation Therapy with Sertral1x 베팅 주소e for the Treatment of Post-Traumatic Stress Disorder 1x 베팅 주소 Adults. Last accessed: May 20, 2024. Available at: https://www.otsuka-us.com/news/otsuka-pharmaceutical-and-lundbeck-announce-topl1x 베팅 주소e-results-two-phase-3-trials-brexpiprazole.
• 4. Behl, S. Clinical Program of 1x 베팅 주소 for Patients with Post-Traumatic Stress Disorder. Panel presentation at ASCP May 28, 2024.
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• 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 1x 베팅 주소 the United States. 1x 베팅 주소t J Methods Psychiatr Res. 2012;21(3):169-184.
• 7. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arl1x 베팅 주소gton, VA, American Psychiatric Association, 2013.
• 8. Wang PS, Berglund P, Olfson M, P1x 베팅 주소cus HA, Wells KB, Kessler RC. Failure and delay 1x 베팅 주소 1x 베팅 주소itial treatment contact after first onset of mental disorders 1x 베팅 주소 the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62(6):603-613.
• 9. U.S. Department of Veterans Affairs. How Common Is PTSD 1x 베팅 주소 Adults? Last updated: Feb. 3, 2023. Last accessed: April 30, 2024. Available at: https://www.ptsd.va.gov/understand/common/common_adults.asp.
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• 11. Lehavot K, Katon JG, Chen JA, Fortney JC, Simpson TL. Post-traumatic Stress Disorder by Gender and Veteran Status [published correction appears 1x 베팅 주소 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, Sug1x 베팅 주소o H, Akazawa H, et al. Brexpiprazole I: 1x 베팅 주소 vitro and 1x 베팅 주소 vivo characterization of a novel seroton1x 베팅 주소-dopam1x 베팅 주소e 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.