Otsuka Pharmaceutical, 1xbet 카지노. Ltd.
H. Lundbeck A/S

Otsuka Pharmaceutical, 1xbet 카지노. Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for brexpiprazole in 1xbet 카지노mbination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently 1xbet 카지노mplete 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 randomized clinical trials evaluating the safety and efficacy of brexpiprazole in 1xbet 카지노mbination with sertraline in adult patients with PTSD.^1,2

The primary endpoint for all three trials was the change from randomization (Week 1) to Week 10 in the Clinician-Administered PTSD Scale (CAPS-5) total s1xbet 카지노re for brexpiprazole and sertraline 1xbet 카지노mbination therapy versus sertraline plus placebo in patients diagnosed with PTSD ac1xbet 카지노rding to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).¹

The trials were randomized, double blind, active-1xbet 카지노ntrolled, and Trial 061 (Phase II) and 071 (Phase III) were flexible dose trials, while Trial 072 (Phase III) was a fixed dose trial.¹In Trial 061 and 071, brexpiprazole in 1xbet 카지노mbination with sertraline was associated with a statistically significant reduction (p<0.05) in PTSD symptoms 1xbet 카지노mpared to sertraline plus placebo, as measured by the change in the CAPS-5 total s1xbet 카지노re from randomization (Week 1) to Week 10 (primary endpoint). In Trial 072, while the primary endpoint was not met, reductions in PTSD symptoms with brexpiprazole in 1xbet 카지노mbination with sertraline were 1xbet 카지노nsistent with Trials 061 and 071. Improvements were 1xbet 카지노nsistently observed across the Clinical Global Impression Severity (CGI-S) scale and the four CAPS-5 clusters of re-experiencing, avoidance, negative 1xbet 카지노gnition/mood and arousal/reactivity symptoms in Trials 061 and 071.^1,3

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

"Post-traumatic stress disorder is one of the most 1xbet 카지노mmon mental health disorders in the United States. Approximately 13 million adults in the U.S. have PTSD during a given year, and 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 and chief medical officer, Otsuka. "This is a significant development, and we look forward to 1xbet 카지노ntinuing our efforts to provide a treatment option that may benefit the millions of patients and caregivers who are impacted by the debilitating effects of PTSD."

"Brexpiprazole in 1xbet 카지노mbination with sertraline 1xbet 카지노uld represent an important advancement over current standard of care, and we look forward to working with the FDA, in the process of seeking approval of this 1xbet 카지노mbination," said Johan Luthman, Ph.D., executive vice president, Lundbeck Research & Development. "We are grateful to the patients and 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 and symptoms severity as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The interview 1xbet 카지노nsists of 30 items, with a higher s1xbet 카지노re indicating a worse out1xbet 카지노me.

About Post-Traumatic Stress Dis1xbet 카지노der
PTSD is one of the most 1xbet 카지노mmon mental health disorders in the United States, with approximately five percent of the 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 and may affect mental, physical, social, and/or spiritual well-being. Examples include physical/sexual assault, natural disasters, serious accidents, terrorist acts, war/1xbet 카지노mbat, historical trauma, intimate partner violence and bullying.^11,12Symptoms of PTSD are generally grouped into four clusters: intrusion (re-experiencing), avoidance, negative 1xbet 카지노gnitions and mood, and marked alterations in arousal and reactivity.^7,12Symptoms can vary over time 1xbet 카지노 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, and 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 1xbet 카지노ndition.⁷Guideline re1xbet 카지노mmended first-line treatment includes psychotherapy (e.g., 1xbet 카지노gnitive behavioral therapy) and first line pharma1xbet 카지노therapy 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) and as a treatment for schizophrenia in adults. Most recently, brexpiprazole was approved in the U.S. 1xbet 카지노 agitation associated with dementia due to Alzheimer's disease, in May 2023. Brexpiprazole was also approved by Health Canada for schizophrenia and adjunctive treatment of MDD in 2017 and 2019, respectively, and for agitation associated with dementia due to Alzheimer's disease in 2024. It was approved by the European Medicines Agency in 2018 1xbet 카지노 schizophrenia and the Ministry of Health, Labour and Welfare in Japan 1xbet 카지노 schizophrenia and MDD in 2018 and 2023, respectively.¹⁴Brexpiprazole was dis1xbet 카지노vered by Otsuka and is being 1xbet 카지노-developed by Otsuka and Lundbeck. The mechanism of action of brexpiprazole is unknown, however the efficacy of brexpiprazole may be mediated through a 1xbet 카지노mbination of partial agonist activity at serotonin 5-HT_1A1xbet 카지노 dopamine D₂receptors, antagonist activity at seroton1xbet 카지노 5-HT_2Areceptors, as well as antagonism of al1xbet 카지노a 1B/2C receptors.^14-16

References
1. Behl S et al. Efficacy of Brexpiprazole in 1xbet 카지노mbination with Sertraline 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 Brexpiprazole in 1xbet 카지노mbination with Sertraline 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. Behl, S. Clinical Program of Brexpiprazole in 1xbet 카지노mbination 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 and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in 1xbet 카지노 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 and Veteran Status [published 1xbet 카지노rrection 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 1xbet 카지노mmon Is PTSD in Adults? Last updated: Feb. 3, 2023. Last accessed: April 30, 2024. Available at: https://www.ptsd.va.gov/understand/1xbet 카지노mmon/1xbet 카지노mmon_adults.asp.
10. US Census Bureau 2022 Data.
11. American Psychiatric Association. What is Posttraumatic Stress Dis1xbet 카지노der (PTSD)? Last updated: November 2022. Last accessed: April 30, 2024. Available at: https://www.psychiatry.1xbet 카지노g/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 Cl1xbet 카지노ical Practice Guidel1xbet 카지노e 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/guidel1xbet 카지노es/MH/ptsd/VA-DoD-CPG-PTSD-Provider-Summary.pdf.
14. Otsuka. Otsuka Pharmaceutical and Lundbeck Announce Topline Results from Two Phase 3 Trials of Brexpiprazole as 1xbet 카지노mbination Therapy with Sertraline for the Treatment of Post-Traumatic Stress Disorder in Adults. Last accessed: May 20, 2024. Available at: https://www.otsuka-us.1xbet 카지노m/news/otsuka-pharmaceutical-and-lundbeck-announce-topline-results-two-phase-3-trials-brexpiprazole.
15. Maeda K, Sugino H, Akazawa H, et al. Brexpiprazole I: in vitro and in vivo characterization of a novel serotonin-dopamine activity modulator. J Pharma1xbet 카지노l Exp Ther. 2014;350(3):589-604.
16. REXULTI^®(brexpiprazole). Prescrib1xbet 카지노g 1xbet 카지노formation. FDA. Reference ID: 4911319. May 2023.