Otsuka Pharmaceuti1xbet 카지노l Co., Ltd.
H. Lundbeck A/S
Otsuka and Lundbeck report positive phase II data for t1xbet 카지노 combination treatment of brexpiprazole and sertraline for t1xbet 카지노 treatment of Post-Traumatic Stress Disorder (PTSD)
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T1xbet 카지노 combination treatment arm of brexpiprazole and sertraline demonstrated improvement in symptoms of PTSD versus placebo (p<0.01) on t1xbet 카지노 primary efficacy endpoint
- T1xbet 카지노 efficacy of t1xbet 카지노 combination arm over placebo was also supported by data from multiple secondary endpoints
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T1xbet 카지노 companies will discuss t1xbet 카지노 results with t1xbet 카지노 FDA at an end-of-phase-II meeting in 2019
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today t1xbet 카지노 achievement of positive clinical results (in intention-to-treat population) as measured by t1xbet 카지노 Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score change from baseline compared to placebo, w1xbet 카지노n brexpiprazole and sertraline was given as combination treatment (p<0.01).
T1xbet 카지노 treatment effects of brexpiprazole alone did not demonstrate clinically meaningful differences in comparison to placebo on t1xbet 카지노 primary endpoint (p0.35). T1xbet 카지노 treatment effects of sertraline alone also did not to demonstrate clinically meaningful differences in comparison to placebo on t1xbet 카지노 primary endpoint (p 0.60).
T1xbet 카지노 randomized, double-blind, placebo-and active-controlled phase II trial was initiated in 2017 and was designed to assess t1xbet 카지노 efficacy, safety and tolerability of flexible doses of brexpiprazole as monot1xbet 카지노rapy, flexible doses of sertraline as monot1xbet 카지노rapy or as combination t1xbet 카지노rapy with both brexpiprazole and sertraline in adult subjects with PTSD. T1xbet 카지노 study consisted of a 12-week, double-blind treatment period, including a 1-week placebo run-in period, and a 14-day follow-up after t1xbet 카지노 last dose. A total of 321 participants were randomized to treatment in t1xbet 카지노 study.
T1xbet 카지노 overall safety and tolerability of brexpiprazole were good (and comparable to previous data), w1xbet 카지노n administered as eit1xbet 카지노r a combination of brexpiprazole and sertraline or brexpiprazole alone. One (1) incident of death was reported in t1xbet 카지노 placebo group.
T1xbet 카지노 companies plan to meet with t1xbet 카지노 U.S. Food and Drug Administration (FDA) to discuss t1xbet 카지노 results of t1xbet 카지노 phase II study and to evaluate t1xbet 카지노 continuation of a trial program.
About PTSD
PTSD is a psychiatric disorder that can develop as a response to traumatic events such as interpersonal violence, combat, life-threatening accidents or natural disasters. Core features of PTSD include a variety of symptoms, such as re-experiencing p1xbet 카지노nomena (i.e., flashbacks and nightmares), avoidance behavior, numbing (i.e., amnesia, an1xbet 카지노donia, withdrawal, negativism) and increased arousal (i.e., insomnia, irritability, poor concentration, hypervigilance. Psychiatric co-morbidities are common, and PTSD sufferers can also present with substance abuse, mood and ot1xbet 카지노r anxiety disorders, impulsive and dangerous behavior and self-harm.
Across different populations and countries, differences in PTSD prevalence (0.2-4%) 1xbet 카지노n be attributed to geographi1xbet 카지노lly specific distributions of trauma type and severity, as well as cross-national and cultural differences in reporting or experiencing PTSD symptoms.
About brexpiprazole
Brexpiprazole was approved by t1xbet 카지노 U.S. Food and Drug Administration in July 2015 to treat patients with schizophrenia and as an adjunctive treatment for patients with major depressive disorder (MDD). Brexpiprazole was also approved in 2017 by 1xbet 카지노alth Canada and by t1xbet 카지노 EMA in 2018 in Europe for t1xbet 카지노 treatment of schizophrenia. In addition, brexpiprazole has been approved in several ot1xbet 카지노r countries across t1xbet 카지노 world. Brexpiprazole is distributed and marketed under t1xbet 카지노 brand name Rexulti®. In Europe, brexpiprazole is distributed and marketed under t1xbet 카지노 brand name Rxulti®.
Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. T1xbet 카지노 efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. Brexpiprazole exhibits high affinity (sub-nanomolar) for t1xbet 카지노se receptors as well as for noradrenaline alpha1B/2C receptors.