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January 10, 2025

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

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

The FDA's decision to host a PDAC meeting does not reflect a final decision on the approvability. A final date for the meeting has yet to be set by the FDA, but it is currently anticipated to occur during the first half 1xbet 후기 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 Disorder

PTSD is one 1xbet 후기 the most common mental health disorders in the United States, with approximately five percent 1xbet 후기 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 1xbet 후기 events or set 1xbet 후기 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 1xbet 후기 traumatic events include physical/sexual assault, natural disasters, serious accidents, terrorist acts, war/combat, historical trauma, intimate partner violence and bullyingvii,viii.

Symptoms 1xbet 후기 PTSD are generally grouped into four symptom clusters: intrusion (re-experiencing), avoidance, negative cognitions 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 1xbet 후기 daily life, such as relationships or work. Symptoms also must not be due to medications, substance use, or another medical condition. Guideline-recommended first-line treatment includes psychotherapy (e.g., cognitive behavioral therapy) and first line pharmacotherapy options include certain antidepressantsx.

About brexpiprazole

Brexpiprazole was approved in the U.S. by FDA 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. for the treatment 1xbet 후기 agitation associated with dementia due to Alzheimer's disease, in May 2023. Brexpiprazole was also approved by Health Canada for schizophrenia and adjunctive treatment 1xbet 후기 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 for the treatment 1xbet 후기 schizophrenia and the Ministry 1xbet 후기 Health, Labour and Welfare in Japan for the treatment 1xbet 후기 schizophrenia and MDD in 2018 and 2023, respectively.

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

Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The mechanism 1xbet 후기 action 1xbet 후기 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 1xbet 후기 anxiety and mood disorders in the United States. Int 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 correction appears 1xbet 후기 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 1xbet 후기 Evidence-Based Assessment and Treatment. J Clin Med. 2016;5(11):105.
    4. ivU.S. Department 1xbet 후기 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/understand/common/common_adults.asp
    5. vDavis LL, Schein J, Cloutier M, et al. The Economic Burden 1xbet 후기 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-1xbet 후기-onset distributions 1xbet 후기 DSM-IV disorders in the National Comorbidity Survey Replication [published correction 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 1xbet 후기 Mental Disorders, Fifth Edition. Arlington, VA, American Psychiatric Association, 2013
    8. viiiAmerican Psychiatric Association. What is Posttraumatic Stress Disorder (PTSD)? Last updated: November 2022. Last accessed: August 28, 2024. Available at: https://www.psychiatry.org/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 contact after first onset 1xbet 후기 mental disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62(6):603-613.
    10. xU.S. Department 1xbet 후기 Veterans Affairs. VA/DoD Clinical Practice Guidelines. Management 1xbet 후기 Posttraumatic Stress Disorder and Acute Stress Disorder. Provider Summary 2023. Version 4.0. www.healthquality.va.gov/guidelines/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 1xbet 후기 a novel serotonin-dopamine activity modulator. J Pharmacol Exp Ther. 2014;350(3):589-604.
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