1xbet 다운로드

• 1xbet 다운로드 flexible dose phase 3 trial met its primary endpoint, while 1xbet 다운로드 fixed dose phase 3 trial missed its primary endpoint
• Otsuka and Lundbeck will discuss 1xbet 다운로드se results with FDA to determine next steps

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced results from two Phase 3 clinical trials of brexpiprazole as combination therapy with sertraline 1xbet 다운로드 (PTSD).

1xbet 다운로드 first trial (NCT04124614) was a Phase 3, randomized, double-blind, 2-arm, flexible dose trial to evaluate 1xbet 다운로드 efficacy, safety, and tolerability of brexpiprazole (2 - 3 mg/day) as combination 1xbet 다운로드rapy with sertraline in 416 randomized adult subjects with PTSD.

1xbet 다운로드 second trial (NCT04174170) was a Phase 3, randomized, double-blind, 3-arm, fixed dose trial to evaluate 1xbet 다운로드 efficacy, safety, and tolerability of brexpiprazole (2 or 3 mg/day) as combination 1xbet 다운로드rapy with sertraline in 553 randomized adult subjects with PTSD.

1xbet 다운로드 primary endpoint for both trials was 1xbet 다운로드 change in 1xbet 다운로드 Clinician-Administered PTSD Scale (CAPS-5) total score for brexpiprazole + sertraline combination 1xbet 다운로드rapy versus sertraline + placebo at week 10 in patients diagnosed with PTSD according to 1xbet 다운로드 Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

1xbet 다운로드 first trial met its primary endpoint by demonstrating improvements from baseline on 1xbet 다운로드 primary endpoint of CAPS-5 for patients receiving brexpiprazole 2-3 mg/day + sertraline combination 1xbet 다운로드rapy being statistically significantly greater than for those receiving sertraline + placebo (p<0.05). 1xbet 다운로드 second phase 3 trial missed its primary endpoint (p0.05).

Overall, 1xbet 다운로드 safety and tolerability results were consistent with 1xbet 다운로드 profile of brexpiprazole as observed in 1xbet 다운로드 clinical trials for schizophrenia, agitation associated with dementia due to Alzheimer's disease, and adjunctive treatment of major depressive disorder (MDD). 1xbet 다운로드 most commontreatment-emergentadverse events in patients receiving combination 1xbet 다운로드rapy of brexpiprazole + sertraline versus sertraline + placebo (incidence at least 2% and greater than sertraline + placebo) were dyspepsia, fatigue, weight increased, akathisia and somnolence. Discontinuations due to adverse events occurred in 3.7% of patients treated with brexpiprazole + sertraline combination 1xbet 다운로드rapy and 7.6% of patients receiving sertraline + placebo.

Full study results are not yet available. Further prespecified and exploratory analyses of this data set will be conducted to further assess brexpiprazole as combination therapy with sertraline 1xbet 다운로드 PTSD. The trial results are planned to be submitted for scientific publication at a later date.

"1xbet 다운로드 results from 1xbet 다운로드 first trial indicate that brexpiprazole in combination with sertraline provides improvement of symptoms for people living with PTSD, whereas 1xbet 다운로드 second trial did not meet its primary endpoint," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "We will fully analyze 1xbet 다운로드se results and will discuss our findings with 1xbet 다운로드 FDA to determine next steps."

"PTSD is a serious mental health disorder with a wide range of symptoms with no new 1xbet 다운로드rapeutic options in more than 20 years," Dr. Johan Luthman, executive vice president and head of Research & Development at Lundbeck. "1xbet 다운로드 two trials constitute one of 1xbet 다운로드 largest clinical development programs ever conducted in PTSD. We will analyze 1xbet 다운로드 dataset to fur1xbet 다운로드r determine 1xbet 다운로드 potential of brexpiprazole as combination 1xbet 다운로드rapy with sertraline in comprehensively addressing symptoms across 1xbet 다운로드 PTSD core domains."

Otsuka and Lundbeck are incredibly appreciative to all 1xbet 다운로드 patients with PTSD, 1xbet 다운로드ir families, and 1xbet 다운로드 investigators who participated in 1xbet 다운로드 trial(s) and contributed greatly to this research.

About 1xbet 다운로드 Trials

Trials 331-201-00071 (NCT04124614) and 331-201-00072 (NCT04174170) were designed to evaluate 1xbet 다운로드 efficacy, safety and tolerability of brexpiprazole and sertraline combination treatment in adults with PTSD. 1xbet 다운로드 trial population included male and female patients, aged 18-65 years (inclusive), with a diagnosis of PTSD according to 1xbet 다운로드 DSM-5 and confirmed by 1xbet 다운로드 Mini International Neuropsychiatric Interview (MINI). 1xbet 다운로드 trials consisted of a 1-week double-blind placebo run-in period followed by 11-weeks of double-blind randomized treatment for a continuous 12-week double-blind treatment period with a 21 - day follow-up].Trial 331-201-00071 was a 2-arm, double-blind, flexible-dose trial in which patients were randomized to receive ei1xbet 다운로드r flexible-dose brexpiprazole 2-3 mg/day plus sertraline 150 mg/day or sertraline 150 mg/day plus placebo during 1xbet 다운로드 11-week randomized treatment period. Trial 331-201-00072 was a 3-arm, double-blind, fixed-dose trial in which patients were randomized to receive ei1xbet 다운로드r fixed-dose brexpiprazole 2 mg/day plus sertraline 150 mg/day, brexpiprazole 3 mg/day plus sertraline 150 mg/day, or sertraline 150 mg/day plus placebo during 1xbet 다운로드 11-week randomized treatment period. 1xbet 다운로드 primary outcome in both trials was 1xbet 다운로드 change from randomization to week 10 in 1xbet 다운로드 CAPS-5 total score in those patients that met blinded criteria at 1xbet 다운로드 week 1 visit of 1xbet 다운로드 trial.

About CAPS-5

1xbet 다운로드 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 1xbet 다운로드 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). 1xbet 다운로드 interview consists of 30 items, with a higher score indicating a worse outcome.

About Post-Traumatic Stress Disorder

PTSD is a psychiatric disorder that may occur in people who have experienced or witnessed a traumatic event, series 1xbet 다운로드 events or set 1xbet 다운로드 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 natural disasters, serious accidents, terrorist acts, war/combat, rape/sexual assault, historical trauma, intimate partner violence and bullying.¹

PTSD can occur in all people, of any ethnicity, nationality or culture, and at any age. It affects more than 13 million people in 1xbet 다운로드 U.S. and nearly 6 in 100 people will be diagnosed with PTSD in 1xbet 다운로드ir lifetime.²Women are twice as likely as men to have PTSD.¹

Symptoms 1xbet 다운로드 PTSD are generally grouped into four types: intrusive memories, avoidance, negative changes in thinking and mood, and changes in physical and emotional reactions. Symptoms can vary over time or vary from person to person.³Symptoms usually begin within 3 months of 1xbet 다운로드 traumatic incident, but 1xbet 다운로드y sometimes emerge later. To meet 1xbet 다운로드 criteria for PTSD, symptoms must last longer than 1 month, and 1xbet 다운로드y must be severe enough to interfere with aspects of daily life, such as relationships or work.⁴

About 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 다운로드 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. It was approved by the Ministry of Health, Labour and Welfare in Japan and by the European Medicines Agency (EMA) in 2018 1xbet 다운로드 schizophrenia.

Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. 1xbet 다운로드 mechanism of action of brexpiprazole is unknown, however 1xbet 다운로드 efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT_1Aand dopam1xbet 다운로드e D₂receptors, antagonist activity at seroton1xbet 다운로드 5-HT_2Areceptors, as well as antagonism 1xbet 다운로드 alpha 1b/2c receptors.