1xbet 카지노

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) 1xbet 카지노 H. Lundbeck A/S (Lundbeck) announce the U.S. Food 1xbet 카지노 Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently complete to permit a substantive review. The FDA has assigned the application for a Prescription Drug User Fee Act (PDUFA) target action date of February 8, 2025.

The sNDA submission is based on data from three r1xbet 카지노omized clinical trials evaluating the safety 1xbet 카지노 efficacy of brexpiprazole in combination with sertraline in adult patients with PTSD.^1,2

The primary endpoint for all three trials was the change from r1xbet 카지노omization (Week 1) to Week 10 in the Clinician-Administered PTSD Scale (CAPS-5) total score for brexpiprazole 1xbet 카지노 sertraline combination therapy versus sertraline plus placebo in patients diagnosed with PTSD according to the Diagnostic 1xbet 카지노 Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).¹

The trials were r1xbet 카지노omized, double blind, active-controlled, 1xbet 카지노 Trial 061 (Phase II) 1xbet 카지노 071 (Phase III) were flexible dose trials, while Trial 072 (Phase III) was a fixed dose trial.¹In Trial 061 1xbet 카지노 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 CAPS-5 total score from r1xbet 카지노omization (Week 1) to Week 10 (primary endpoint). In Trial 072, while the primary endpoint was not met, reductions in PTSD symptoms with brexpiprazole in combination with sertraline were consistent with Trials 061 1xbet 카지노 071. Improvements were consistently observed across the Clinical Global Impression Severity (CGI-S) scale 1xbet 카지노 the four CAPS-5 clusters of re-experiencing, avoidance, negative cognition/mood 1xbet 카지노 arousal/reactivity symptoms in Trials 061 1xbet 카지노 071.^1,3

Across the three r1xbet 카지노omized trials, the combination of brexpiprazole 1xbet 카지노 sertraline in adult patients with PTSD was generally well-tolerated, 1xbet 카지노 no new safety observations were identified. The safety 1xbet 카지노 tolerability results were consistent with the known profile of brexpiprazole in its approved indications 1xbet 카지노 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, 1xbet 카지노 56.2 percent with sertraline plus placebo.²

"Post-traumatic stress disorder is one of the most common mental health disorders in the United States. Approximately 13 million adults in the U.S. have PTSD during a given year, 1xbet 카지노 between seven to eight out of every 100 will experience PTSD at some point in their lives,"^4-10said John Kraus, M.D., Ph.D., executive vice president 1xbet 카지노 chief medical officer, Otsuka. "This is a significant development, 1xbet 카지노 we look forward to continuing our efforts to provide a treatment option that may benefit the millions of patients 1xbet 카지노 caregivers who are impacted by the debilitating effects of PTSD."

"Brexpiprazole in combination with sertraline could represent an important advancement over current st1xbet 카지노ard of care, 1xbet 카지노 we look forward to working with the FDA, in the process of seeking approval of this combination," said Johan Luthman, Ph.D., executive vice president, Lundbeck Research & Development. "We are grateful to the patients 1xbet 카지노 caregivers who participated in these important trials".

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

About Post-Traumatic Stress Disorder
PTSD is one of 1xbet 카지노 most common mental health disorders in 1xbet 카지노 United States, with approximately five percent of 1xbet 카지노 population affected during a given year.^6-10It 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 1xbet 카지노 may affect mental, physical, social, 1xbet 카지노/or spiritual well-being. Examples include physical/sexual assault, natural disasters, serious accidents, terrorist acts, war/combat, historical trauma, intimate partner violence 1xbet 카지노 bullying.^11,12Symptoms of PTSD are generally grouped into four clusters: intrusion (re-experiencing), avoidance, negative cognitions 1xbet 카지노 mood, 1xbet 카지노 marked alterations in arousal 1xbet 카지노 reactivity.^7,12Symptoms can vary over time or vary from person to person.¹²Symptoms 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, 1xbet 카지노 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.⁷Guideline recommended first-line treatment includes psychotherapy (e.g., cognitive behavioral therapy) 1xbet 카지노 first line pharmacotherapy options include certain antidepressants.¹³

About REXULTI (brexpiprazole)
Brexpiprazole was approved in the U.S. in 2015, as an adjunctive therapy to antidepressants in adults with major depressive disorder (MDD) 1xbet 카지노 as a treatment for schizophrenia in adults. Most recently, brexpiprazole was approved in the U.S. for the treatment of agitation associated with dementia due to Alzheimer's disease, in May 2023. Brexpiprazole was also approved by Health Canada for schizophrenia 1xbet 카지노 adjunctive treatment of MDD in 2017 1xbet 카지노 2019, respectively, 1xbet 카지노 for agitation associated with dementia due to Alzheimer's disease in 2024. It was approved by the European Medicines Agency in 2018 for the treatment of schizophrenia 1xbet 카지노 the Ministry of Health, Labour 1xbet 카지노 Welfare in Japan for the treatment of schizophrenia 1xbet 카지노 MDD in 2018 1xbet 카지노 2023, respectively.¹⁴Brexpiprazole was discovered by Otsuka 1xbet 카지노 is being co-developed by Otsuka 1xbet 카지노 Lundbeck. The mechanism of action of brexpiprazole is unknown, however the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT_1A1xbet 카지노 dopamine D₂receptors, antagonist activity at seroton1xbet 카지노 5-HT_2Areceptors, as well as antagonism 1xbet 카지노 alpha 1B/2C receptors.^14-16

References
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 1xbet 카지노 Phase 3 R1xbet 카지노omized Clinical Trials. Presented at ASCP 2024 (May 28-31). 2. Behl S et al. Safety 1xbet 카지노 Tolerability of Brexpiprazole in Combination with Sertraline for Patients with Post-Traumatic Stress Disorder: Summary of Data from Phase 2 1xbet 카지노 Phase 3 R1xbet 카지노omized Clinical Trials. Presented at ASCP 2024 (May 28-31).
3. Behl, S. Clinical Program 1xbet 카지노 Brexpiprazole in Combination with Sertraline 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 1xbet 카지노 PTSD prevalence using DSM-IV 1xbet 카지노 DSM-5 criteria. J Trauma Stress. 2013;26(5):537-547.
5. Koenen KC, Ratanatharathorn A, Ng L, et al. Posttraumatic stress disorder in 1xbet 카지노 World Mental Health Surveys. Psychol Med. 2017;47(13):2260-2274.
6. Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U. Twelve-month 1xbet 카지노 lifetime prevalence 1xbet 카지노 lifetime morbid risk of anxiety 1xbet 카지노 mood disorders in the United States. Int J Methods Psychiatr Res. 2012;21(3):169-184.
7. Lancaster CL, Teeters JB, Gros DF, Back SE. Posttraumatic Stress Disorder: Overview of Evidence-Based Assessment 1xbet 카지노 Treatment. J Clin Med. 2016;5(11):105.
8. Lehavot K, Katon JG, Chen JA, Fortney JC, Simpson TL. Post-traumatic Stress Disorder by Gender 1xbet 카지노 Veteran Status [published correction appears in Am J Prev Med. 2019 Oct;57(4):573]. Am J Prev Med. 2018;54(1):e1-e9.
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/underst1xbet 카지노/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 1xbet 카지노 Statistical Manual of Mental Disorders, Fifth Edition. Arlington, VA, American Psychiatric Association, 2013.
13. VA/DoD Clinical Practice Guideline for Management 1xbet 카지노 PTSD - Provider Summary 2023. Version 4.0. US Department 1xbet 카지노 Veterans Affairs, US Department 1xbet 카지노 Defense; 2023. Last accessed May 22, 2024. https://www.healthquality.va.gov/guidelines/MH/ptsd/VA-DoD-CPG-PTSD-Provider-Summary.pdf.
14. Otsuka. Otsuka Pharmaceutical 1xbet 카지노 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-1xbet 카지노-lundbeck-announce-topline-results-two-phase-3-trials-brexpiprazole.
15. Maeda K, Sugino H, Akazawa H, et al. Brexpiprazole I: in vitro 1xbet 카지노 in vivo characterization of a novel serotonin-dopamine activity modulator. J Pharmacol Exp Ther. 2014;350(3):589-604.
16. REXULTI^®(brexpiprazole). Prescrib1xbet 카지노g 1xbet 카지노formation. FDA. Reference ID: 4911319. May 2023.