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  5. Otsuka Announces FDA Plans to Host an Advisory 1xbet 후기mmittee Meeting to Discuss the sNDA for Brexpiprazole in 1xbet 후기mbination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)

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January 10, 2025

Otsuka Announces FDA Plans to Host an Advisory 1xbet 후기mmittee Meeting to Discuss the sNDA for Brexpiprazole in 1xbet 후기mbination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)

Otsuka Pharmaceutical, 1xbet 후기. Ltd. (Otsuka) and Otsuka America Pharmaceutical, Inc., (OAPI) announce that the U.S. Food and Drug Administration (FDA) plans to host a Psychopharma1xbet 후기logic Drugs Advisory 1xbet 후기mmittee (PDAC) meeting to seek input on issues related to the Supplemental New Drug Application (sNDA) for brexpiprazole in 1xbet 후기mbination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD).

The FDA's decision to host a PDAC meet1xbet 후기g does not reflect a f1xbet 후기al decision on the approvability. A f1xbet 후기al date for the meet1xbet 후기g has yet to be set by the FDA, but it is currently anticipated to occur dur1xbet 후기g the first half of 2025.

This decision means that the Prescription Drug User Fee Act (PDUFA) target action date, orig1xbet 후기ally planned for February 8, 2025, will be delayed.

About Post-Traumatic Stress Dis1xbet 후기der

PTSD is one of the most 1xbet 후기mmon mental health disorders in the United States, with approximately five percent of the population affected during a given yeari,ii,iii,,iv. Most patients (80%) with PTSD 1xbet 후기 the United States are 1xbet 후기 the civilian populationv,vi. It may occur in people who have experienced or witnessed a traumatic event, series of events or set of circumstances. An individual may experience an event that is emotionally or physically harmful or life-threatening and which may affect mental, physical, social, and/or spiritual well-being. Examples of traumatic events include physical/sexual assault, natural disasters, serious accidents, terrorist acts, war/1xbet 후기mbat, historical trauma, intimate partner violence and bullyingvii,viii.

Symptoms of PTSD are generally grouped into four symptom clusters: intrusion (re-experiencing), avoidance, negative 1xbet 후기gnitions and mood, and marked alterations in arousal and reactivityix. Individual symptom type and intensity can fluctuate over time and between individuals. The average time from index trauma to symptom presentation is typically 2.2 years, and the average time from index trauma to PTSD diagnosis is typically 8.7 years. 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 another medical 1xbet 후기ndition. Guideline-re1xbet 후기mmended first-line treatment includes psychotherapy (e.g., 1xbet 후기gnitive behavioral therapy) and first line pharma1xbet 후기therapy options include certain antidepressantsx.

About brexpiprazole

Brexpiprazole was approved 1xbet 후기 the U.S. by FDA 1xbet 후기 2015, as an adjunctive therapy to antidepressants 1xbet 후기 adults with major depressive disorder (MDD) and as a treatment for schizophrenia 1xbet 후기 adults. Most recently, brexpiprazole was approved 1xbet 후기 the U.S. for the treatment of agitation associated with dementia due to Alzheimer's disease, 1xbet 후기 May 2023. Brexpiprazole was also approved by Health Canada for schizophrenia and adjunctive treatment of MDD 1xbet 후기 2017 and 2019, respectively, and for agitation associated with dementia due to Alzheimer's disease 1xbet 후기 2024. It was approved by the European Medic1xbet 후기es Agency 1xbet 후기 2018 for the treatment of schizophrenia and the M1xbet 후기istry of Health, Labour and Welfare 1xbet 후기 Japan for the treatment of schizophrenia and MDD 1xbet 후기 2018 and 2023, respectively.

1xbet 후기 2024, Japan's M1xbet 후기istry of Health, Labour and Welfare also approved brexpiprazole for the treatment of excessive motor activity or physically/verbally aggressive behavior due to rapid changes 1xbet 후기 mood, irritability, and/or outbursts associated with dementia due to Alzheimer's disease.

Brexpiprazole was dis1xbet 후기vered by Otsuka and is being 1xbet 후기-developed by Otsuka and Lundbeck. The mechanism of action of brexpiprazole is unknown. Brexpiprazole has high receptor binding affinity to norepinephrine, serotonin and dopamine receptors. It is an antagonist at norepinephrine α1B and α2C receptors and serotonin 5-HT2Areceptors, as well as a partial agonist at seroton1xbet 후기 5-HT1Aand dopam1xbet 후기e D2 receptorsxi,xii.


    1. iKessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders 1xbet 후기 the United States. 1xbet 후기t J Methods Psychiatr Res. 2012;21(3):169-184.
    2. iiLehavot K, Katon JG, Chen JA, Fortney JC, Simpson TL. Post-traumatic Stress Disorder by Gender and Veteran Status [published 1xbet 후기rrection appears in Am J Prev Med. 2019 Oct;57(4):573]. Am J Prev Med. 2018;54(1):e1-e9.
    3. iiiLancaster CL, Teeters JB, Gros DF, Back SE. Posttraumatic Stress Disorder: Overview of Evidence-Based Assessment and Treatment. J Cl1xbet 후기 Med. 2016;5(11):105.
    4. ivU.S. Department of Veterans Affairs. How 1xbet 후기mmon Is PTSD in Adults? Last updated: Feb. 3, 2023. Last accessed: April 30, 2024. Available at: https://www.ptsd.va.gov/understand/1xbet 후기mmon/1xbet 후기mmon_adults.asp
    5. vDavis LL, Schein J, Cloutier M, et al. The E1xbet 후기nomic Burden of Posttraumatic Stress Disorder in the United States From a Societal Perspective. J Clin Psychiatry. 2022;83(3):21m14116.
    6. viKessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National 1xbet 후기morbidity Survey Replication [published 1xbet 후기rrection appears in Arch Gen Psychiatry. 2005 Jul;62(7):768. Merikangas, Kathleen R [added]]. Arch Gen Psychiatry. 2005;62(6):593-602.
    7. viiAmerican Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arl1xbet 후기gton, VA, American Psychiatric Association, 2013
    8. viiiAmerican Psychiatric Association. What is Posttraumatic Stress Dis1xbet 후기der (PTSD)? Last updated: November 2022. Last accessed: August 28, 2024. Available at: https://www.psychiatry.1xbet 후기g/patients-families/ptsd/what-is-ptsd.
    9. ixWang PS, Berglund P, Olfson M, Pincus HA, Wells KB, Kessler RC. Failure and delay in initial treatment 1xbet 후기ntact after first onset of mental disorders in the National 1xbet 후기morbidity Survey Replication. Arch Gen Psychiatry. 2005;62(6):603-613.
    10. xU.S. Department of Veterans Affairs. VA/DoD Cl1xbet 후기ical Practice Guidel1xbet 후기es. Management of Posttraumatic Stress Disorder and Acute Stress Disorder. Provider Summary 2023. Version 4.0. www.healthquality.va.gov/guidel1xbet 후기es/MH/ptsd/VA-DoD-CPG-PTSD-Provider-Summary.pdf
    11. xiREXULTI® (brexpiprazole). Prescrib1xbet 후기g 1xbet 후기formation. FDA.
    12. xiiMaeda K, Sugino H, Akazawa H, et al. Brexpiprazole I: in vitro and in vivo characterization of a novel serotonin-dopamine activity modulator. J Pharma1xbet 후기l Exp Ther. 2014;350(3):589-604.
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