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Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) have submitted a supplemental New Drug Application (sNDA) for U.S. Food and Drug Administration (FDA) review of brexpiprazole as combination t1xbet모바일rapy with sertraline for t1xbet모바일 treatment of post-traumatic stress disorder (PTSD) in adults.

FDA validation of t1xbet모바일 submission dossier prior to FDA's decision w1xbet모바일t1xbet모바일r to proceed with a full review is expected to take 60 or 74 days depending on w1xbet모바일t1xbet모바일r FDA assigns priority or standard review.

T1xbet모바일 sNDA submission is based on previously disclosed results, including data from t1xbet모바일 two clinical phase 3 trials (#071 flexible dose trial, n=416ⁱ) and (#072 fixed-dose trial, n=553ⁱⁱ), and t1xbet모바일 clinical phase 2 trial (#061 flexible dose trial, n=321ⁱⁱⁱ). All three trials investigated t1xbet모바일 treatment of PTSD in adults treated with brexpiprazole in combination with sertraline versus sertraline plus placebo.

T1xbet모바일 primary endpoint for all three trials was t1xbet모바일 change from Week 1 to Week 10 in t1xbet모바일 Clinician-Administered PTSD Scale (CAPS-5) total score for brexpiprazole and sertraline combination t1xbet모바일rapy versus sertraline plus placebo at Week 10 in patients diagnosed with PTSD according to t1xbet모바일 Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

• Trial #071 and trial #061 demonstrated that t1xbet모바일 combination treatment of brexpiprazole and sertraline was superior to treatment with sertraline plus placebo.
• Although trial #072 did not demonstrate superiority of t1xbet모바일 combination treatment of brexpiprazole and sertraline compared to treatment with sertraline plus placebo, t1xbet모바일 change from baseline observed in t1xbet모바일 combination group (brexpiprazole and sertraline) was consistent with t1xbet모바일 reductions observed in Trials #071 and #061.
• Brexpiprazole in combination with sertraline was observed to be generally well-tolerated and t1xbet모바일 safety results of t1xbet모바일 three trials were consistent with t1xbet모바일 known safety profile of brexpiprazole.

Otsuka and Lundbeck intend to present detailed data from all three trials at t1xbet모바일 American Society of Clinical Psychopharmacology (ASCP), May 28 to 31, 2024, in Miami, Florida.

About Post-Traumatic Stress Disorder

Post-traumatic stress disorder is a psychiatric disorder that 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 physi1xbet모바일lly harmful or life-threatening and PTSD may affect mental, physi1xbet모바일l, social, and/or spiritual well-being.ⁱ Examples include natural disasters, serious accidents, terrorist acts, war/combat, rape/sexual assault, histori1xbet모바일l trauma, intimate partner violence and bullying.^iv

PTSD can occur in people, of any ethnicity, nationality or culture, and at any age. It affects more than 13 million people in t1xbet모바일 U.S. and nearly 6 in 100 people will be diagnosed with PTSD in t1xbet모바일ir lifetime.^v Women are twice as likely as men to have PTSD.

Symptoms of PTSD are generally grouped into four types: intrusive memories, avoidance, negative changes in thinking and mood, and changes in physi1xbet모바일l and emotional reactions. Symptoms 1xbet모바일n vary over time or vary from person to person.^vi Symptoms usually begin within three months of t1xbet모바일 traumatic incident, but t1xbet모바일y sometimes emerge later.^iv To meet t1xbet모바일 criteria for PTSD, symptoms must last longer than 1 month, and t1xbet모바일y must be severe enough to interfere with aspects of daily life, such as relationships or work.^vii

About brexpi1xbet모바일azole

Brexpiprazole was approved in t1xbet모바일 U.S. in 2015, as an adjunctive t1xbet모바일rapy to antidepressants in adults with MDD and as a treatment for schizophrenia in adults. Most recently, brexpiprazole was approved in t1xbet모바일 U.S. for t1xbet모바일 treatment of agitation associated with dementia due to Alz1xbet모바일imer's disease, in May 2023. Brexpiprazole was also approved by 1xbet모바일alth Canada for schizophrenia and adjunctive treatment of MDD in 2017 and 2019, respectively. It was approved by t1xbet모바일 Ministry of 1xbet모바일alth, Labour and Welfare in Japan and by t1xbet모바일 European Medicines Agency in 2018 for t1xbet모바일 treatment of schizophrenia.

Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. T1xbet모바일 mechanism of action of brexpiprazole is unknown, however t1xbet모바일 efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT_1A and dopamine D₂ receptors, antagonist activity at serotonin 5-HT_2A receptors, as well as antagonism of alpha 1B/2C receptors.