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Otsuka Pharmaceutical Co., Ltd. (Otsuka) 1xbet모바일 H. Lundbeck A/S (Lundbeck) have submitted a supplemental New Drug Application (sNDA) for U.S. Food 1xbet모바일 Drug Administration (FDA) review of brexpiprazole as combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD) in adults.

FDA validation of the submission dossier prior to FDA's decision whether to proceed with a full review is expected to take 60 or 74 days depending on whether FDA assigns priority or st1xbet모바일ard review.

The sNDA submission is based on previously disclosed results, 1xbet모바일clud1xbet모바일g data from the two cl1xbet모바일ical phase 3 trials (#071 flexible dose trial, n=416ⁱ) 1xbet모바일 (#072 fixed-dose trial, n=553ⁱⁱ), 1xbet모바일 the clinical phase 2 trial (#061 flexible dose trial, n=321ⁱⁱⁱ). All three trials investigated the treatment 1xbet모바일 PTSD in adults treated with brexpiprazole in combination with sertraline versus sertraline plus placebo.

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

• Trial #071 1xbet모바일 trial #061 demonstrated that the combination treatment of brexpiprazole 1xbet모바일 sertraline was superior to treatment with sertraline plus placebo.
• Although trial #072 did not demonstrate superiority of the combination treatment of brexpiprazole 1xbet모바일 sertraline compared to treatment with sertraline plus placebo, the change from baseline observed in the combination group (brexpiprazole 1xbet모바일 sertraline) was consistent with the reductions observed in Trials #071 1xbet모바일 #061.
• Brexpiprazole in combination with sertraline was observed to be generally well-tolerated 1xbet모바일 the safety results of the three trials were consistent with the known safety profile of brexpiprazole.

Otsuka 1xbet모바일 Lundbeck intend to present detailed data from all three trials at the 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 physically harmful or life-threatening 1xbet모바일 PTSD may affect mental, physical, social, 1xbet모바일/or spiritual well-being.ⁱExamples include natural disasters, serious accidents, terrorist acts, war/combat, rape/sexual assault, historical trauma, intimate partner violence 1xbet모바일 bullying.^iv

PTSD can occur in people, of any ethnicity, nationality or culture, 1xbet모바일 at any age. It affects more than 13 million people in the U.S. 1xbet모바일 nearly 6 in 100 people will be diagnosed with PTSD in their lifetime.^vWomen 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 1xbet모바일 mood, 1xbet모바일 changes in physical 1xbet모바일 emotional reactions. Symptoms can vary over time or vary from person to person.^viSymptoms usually begin within three months 1xbet모바일 the traumatic incident, but they sometimes emerge later.^ivTo meet the criteria for PTSD, symptoms must last longer than 1 month, 1xbet모바일 they must be severe enough to interfere with aspects of daily life, such as relationships or work.^vii

About brexpiprazole

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

Brexpiprazole was discovered by Otsuka 1xbet모바일 is being co-developed by Otsuka 1xbet모바일 Lundbeck. The mechanism of action of brexpiprazole is unknown, however the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT_1A1xbet모바일 dopamine D₂receptors, antagonist activity at seroton1xbet모바일 5-HT_2Areceptors, as well as antagonism 1xbet모바일 alpha 1B/2C receptors.