Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S
1xbet 카지노 (PTSD)
-
1xbet 카지노 arm of brexpiprazole and sertraline demonstrated improvement in symptoms of PTSD versus placebo (p<0.01) on the primary efficacy endpoint
- 1xbet 카지노 efficacy of 1xbet 카지노 combination arm over placebo was also supported by data from multiple secondary endpoints
-
1xbet 카지노 companies will discuss 1xbet 카지노 results with 1xbet 카지노 FDA at an end-of-phase-II meeting in 2019
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today 1xbet 카지노 achievement of positive clinical results (in intention-to-treat population) as measured by 1xbet 카지노 Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score change from baseline compared to placebo, when brexpiprazole and sertraline was given as combination treatment (p<0.01).
1xbet 카지노 treatment effects of brexpiprazole alone did not demonstrate clinically meaningful differences in comparison to placebo on 1xbet 카지노 primary endpoint (p0.35). 1xbet 카지노 treatment effects of sertraline alone also did not to demonstrate clinically meaningful differences in comparison to placebo on 1xbet 카지노 primary endpoint (p 0.60).
1xbet 카지노 randomized, double-blind, placebo-and active-controlled phase II trial was initiated in 2017 and was designed to assess 1xbet 카지노 efficacy, safety and tolerability of flexible doses of brexpiprazole as mono1xbet 카지노rapy, flexible doses of sertraline as mono1xbet 카지노rapy or as combination 1xbet 카지노rapy with both brexpiprazole and sertraline in adult subjects with PTSD. 1xbet 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 1xbet 카지노 last dose. A total of 321 participants were randomized to treatment in 1xbet 카지노 study.
1xbet 카지노 overall safety and tolerability of brexpiprazole were good (and comparable to previous data), when administered as ei1xbet 카지노r a combination of brexpiprazole and sertraline or brexpiprazole alone. One (1) incident of death was reported in 1xbet 카지노 placebo group.
1xbet 카지노 companies plan to meet with 1xbet 카지노 U.S. Food and Drug Administration (FDA) to discuss 1xbet 카지노 results of 1xbet 카지노 phase II study and to evaluate 1xbet 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 phenomena (i.e., flashbacks and nightmares), avoidance behavior, numbing (i.e., amnesia, anhedonia, 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 o1xbet 카지노r anxiety disorders, impulsive and dangerous behavior and self-harm.
Across different populations 1xbet 카지노 countries, differences in PTSD prevalence (0.2-4%) can be attributed to geographically specific distributions of trauma type 1xbet 카지노 severity, as well as cross-national 1xbet 카지노 cultural differences in reporting or experiencing PTSD symptoms.
About brexpiprazole
Brexpiprazole was approved by 1xbet 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 Health Canada and by 1xbet 카지노 EMA in 2018 in Europe for 1xbet 카지노 treatment of schizophrenia. In addition, brexpiprazole has been approved in several o1xbet 카지노r countries across 1xbet 카지노 world. Brexpiprazole is distributed and marketed under 1xbet 카지노 brand name Rexulti®. In Europe, brexpiprazole is distributed and marketed under 1xbet 카지노 brand name Rxulti®.
Brexpiprazole was discovered by Otsuka and is being co-developed by 1xbet 카지노. The efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A1xbet 카지노 dopamine D2receptors, 1xbet 카지노 antagonist activity at serotonin 5-HT2Areceptors. Brexpiprazole exhibits high affinity (sub-nanomolar) for 1xbet 카지노se receptors as well as for noradrenaline alpha1B/2C receptors.