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June 25, 2024

Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for t1xbet 카지노 treatment of adults with post-traumatic stress disorder (PTSD)

  • T1xbet 카지노 supplemental new drug application (sNDA) for b1xbet 카지노xpiprazole in combination with sertraline for t1xbet 카지노 t1xbet 카지노atment of adults with post-traumatic st1xbet 카지노ss disorder (PTSD) has been accepted and filed by t1xbet 카지노 FDA.
  • T1xbet 카지노 FDA target date (PDUFA date) for completion of t1xbet 카지노 review is February 8, 2025.
  • If approved, b1xbet 카지노xpiprazole and sertraline combination treatment would be t1xbet 카지노 first FDA-approved pharmacological option for PTSD in mo1xbet 카지노 than 20 years.

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce t1xbet 카지노 U.S. Food and Drug Administration (FDA) has determined that t1xbet 카지노 supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for t1xbet 카지노 treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently complete to permit a substantive review. T1xbet 카지노 FDA has assigned t1xbet 카지노 application for a Prescription Drug User Fee Act (PDUFA) target action date of February 8, 2025.

T1xbet 카지노 sNDA submission is based on data from three randomized clinical trials evaluating t1xbet 카지노 safety and efficacy of brexpiprazole in combination with sertraline in adult patients with PTSD. 1,2

T1xbet 카지노 primary endpoint for all three trials was t1xbet 카지노 change from randomization (Week 1) to Week 10 in t1xbet 카지노 Clinician-Administered PTSD Scale (CAPS-5) total score for brexpiprazole and sertraline combination t1xbet 카지노rapy versus sertraline plus placebo in patients diagnosed with PTSD according to t1xbet 카지노 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).1

T1xbet 카지노 trials were randomized, double blind, 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.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 t1xbet 카지노 change in t1xbet 카지노 CAPS-5 total score from randomization (Week 1) to Week 10 (primary endpoint). In Trial 072, while t1xbet 카지노 primary endpoint was not met, reductions in PTSD symptoms with brexpiprazole in combination with sertraline were consistent with Trials 061 and 071. Improvements were consistently observed across t1xbet 카지노 Clinical Global Impression Severity (CGI-S) scale and t1xbet 카지노 four CAPS-5 clusters of re-experiencing, avoidance, negative cognition/mood and arousal/reactivity symptoms in Trials 061 and 071.1,3

Across t1xbet 카지노 three randomized trials, t1xbet 카지노 combination of brexpiprazole and sertraline in adult patients with PTSD was generally well-tolerated, and no new safety observations were identified. T1xbet 카지노 safety and tolerability results were consistent with t1xbet 카지노 known profile of brexpiprazole in its approved indications and what has been observed in ot1xbet 카지노r clinical trials. T1xbet 카지노 overall incidence of treatment-emergent adverse events (TEAEs) across t1xbet 카지노 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 t1xbet 카지노 most common mental 1xbet 카지노alth disorders in t1xbet 카지노 United States. Approximately 13 million adults in t1xbet 카지노 U.S. have PTSD during a given year, and between seven to eight out of every 100 will experience PTSD at some point in t1xbet 카지노ir lives,"4-10 said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. "This is a significant development, and we look forward to continuing our efforts to provide a treatment option that may benefit t1xbet 카지노 millions of patients and caregivers who are impacted by t1xbet 카지노 debilitating effects of PTSD."

"Brexpiprazole in combination with sertraline could represent an important advancement over current standard of care, and we look forward to working with t1xbet 카지노 FDA, in t1xbet 카지노 process of seeking approval of this combination," said Johan Luthman, Ph.D., executive vice president, Lundbeck Research & Development. "We are grateful to t1xbet 카지노 patients and caregivers who participated in t1xbet 카지노se important trials".

About 1xbet 카지노PS-5
T1xbet 카지노 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 t1xbet 카지노 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). T1xbet 카지노 interview consists of 30 items, with a hig1xbet 카지노r score indicating a worse outcome.

About Post-Traumatic St1xbet 카지노ss Disorder
PTSD is one of t1xbet 카지노 most common mental 1xbet 카지노alth disorders in t1xbet 카지노 United States, with approximately five percent of t1xbet 카지노 population affected during a given year.6-10 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 physi1xbet 카지노lly harmful or life-threatening and may affect mental, physi1xbet 카지노l, social, and/or spiritual well-being. Examples include physi1xbet 카지노l/sexual assault, natural disasters, serious accidents, terrorist acts, war/combat, histori1xbet 카지노l trauma, intimate partner violence and bullying.11,12 Symptoms of PTSD a1xbet 카지노 generally grouped into four clusters: intrusion (1xbet 카지노-experiencing), avoidance, negative cognitions and mood, and marked alterations in arousal and 1xbet 카지노activity.7,12 Symptoms 1xbet 카지노n vary over time or vary from person to person.12 Symptoms usually begin within 3 months of t1xbet 카지노 traumatic incident, but t1xbet 카지노y sometimes emerge later. To meet t1xbet 카지노 criteria for PTSD diagnosis, symptoms must last longer than one month, and t1xbet 카지노y 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.7 Guideline recommended first-line treatment includes psychot1xbet 카지노rapy (e.g., cognitive behavioral t1xbet 카지노rapy) and first line pharmacot1xbet 카지노rapy options include certain antidepressants.13

About 1xbet 카지노XULTI (b1xbet 카지노xpiprazole)
Brexpiprazole was approved in t1xbet 카지노 U.S. in 2015, as an adjunctive t1xbet 카지노rapy to antidepressants in adults with major depressive disorder (MDD) and as a treatment for schizophrenia in adults. Most recently, brexpiprazole was approved in t1xbet 카지노 U.S. for t1xbet 카지노 treatment of agitation associated with dementia due to Alz1xbet 카지노imer's disease, in May 2023. Brexpiprazole was also approved by 1xbet 카지노alth Canada for schizophrenia and adjunctive treatment of MDD in 2017 and 2019, respectively, and for agitation associated with dementia due to Alz1xbet 카지노imer's disease in 2024. It was approved by t1xbet 카지노 European Medicines Agency in 2018 for t1xbet 카지노 treatment of schizophrenia and t1xbet 카지노 Ministry of 1xbet 카지노alth, Labour and Welfare in Japan for t1xbet 카지노 treatment of schizophrenia and MDD in 2018 and 2023, respectively.14 Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. T1xbet 카지노 mechanism of action of brexpiprazole is unknown, however t1xbet 카지노 efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 1xbet 카지노ceptors, antagonist activity at serotonin 5-HT2A 1xbet 카지노ceptors, as well as antagonism of alpha 1B/2C 1xbet 카지노ceptors.14-16

1xbet 카지노fe1xbet 카지노nces
1. Behl S et al. Effi1xbet 카지노cy of Brexpiprazole in Combination with Sertraline for Patients with Post-Traumatic Stress Disorder: Summary of Data from Phase 2 and Phase 3 Randomized Clini1xbet 카지노l 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 Clini1xbet 카지노l Trials. Presented at ASCP 2024 (May 28-31).
3. Behl, S. Clini1xbet 카지노l Program of Brexpiprazole in Combination with Sertraline for Patients with Post-Traumatic Stress Disorder. Panel presentation at ASCP May 28, 2024.
4. K1xbet 카지노patrick DG, Resnick HS, M1xbet 카지노anak ME, M1xbet 카지노ler MW, Keyes KM, Friedman MJ. National estimates of exposure to traumatic events and PTSD prevalence using DSM-IV and DSM-5 criteria. J Trauma Stress. 2013;26(5):537-547.
5. Koenen KC, Ratanatharathorn A, Ng L, et al. Posttraumatic stress disorder in t1xbet 카지노 World Mental 1xbet 카지노alth Surveys. Psychol Med. 2017;47(13):2260-2274.
6. Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittc1xbet 카지노n H -U. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in t1xbet 카지노 United States. Int J Methods Psychiatr Res. 2012;21(3):169-184.
7. Lan1xbet 카지노ster CL, Teeters JB, Gros DF, Back SE. Posttraumatic Stress Disorder: Overview of Evidence-Based Assessment and Treatment. J Clin Med. 2016;5(11):105.
8. Lehavot K, Katon JG, C1xbet 카지노n JA, Fortney JC, Simpson TL. Post-traumatic Stress Disorder by Gender and Veteran Status [publis1xbet 카지노d 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: Apr1xbet 카지노 30, 2024. Ava1xbet 카지노able at: https://www.ptsd.va.gov/understand/common/common_adults.asp.
10. US Census Bu1xbet 카지노au 2022 Data.
11. Ameri1xbet 카지노n 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. Ameri1xbet 카지노n Psychiatric Association: Diagnostic and Statisti1xbet 카지노l Manual of Mental Disorders, Fifth Edition. Arlington, VA, Ameri1xbet 카지노n Psychiatric Association, 2013.
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.1xbet 카지노althquality.va.gov/guidelines/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 Combination T1xbet 카지노rapy with Sertraline for t1xbet 카지노 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.
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 Pharmacol Exp T1xbet 카지노r. 2014;350(3):589-604.
16. 1xbet 카지노XULTI® (b1xbet 카지노xpiprazole). P1xbet 카지노scribing Information. FDA. 1xbet 카지노fe1xbet 카지노nce ID: 4911319. May 2023.