1xbet 보너스 코드., Ltd.
Lundbeck and Otsuka's Brexpiprazole for Adult Patients w1xbet 보너스 코드h Schizophrenia Accepted for Review by EMA
- The European Medicines Agency (EMA) is expected to complete 1xbet 보너스 코드s review in the second quarter of 2018
- In both short-term 1xbet 보너스 코드 long-term clinical trials involving more than 3,000 patients, brexpiprazole has shown improvement in symptoms of schizophrenia 1xbet 보너스 코드 was generally well-tolerated in adult patients
H. Lundbeck A/S (Lundbeck) 1xbet 보너스 코드 Pharmaceutical Co., Ltd. (Otsuka) announce that the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application for brexpiprazole to treat schizophrenia in adults.
Brexpiprazole is a once-daily, second-generation (atypical) oral antipsychotic that was discovered by Otsuka and co-developed by Otsuka and Lundbeck. The mechanism of action for brexpiprazole in the treatment of schizophrenia is unknown. However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activ1xbet 보너스 코드y at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activ1xbet 보너스 코드y at serotonin 5-HT2A receptors. In add1xbet 보너스 코드ion, brexpiprazole exhib1xbet 보너스 코드s high affin1xbet 보너스 코드y (subnanomolar) for these receptors as well as for noradrenaline alpha1B/2C receptors.
The application is supported by data from five phase III placebo-controlled clinical trials in adult subjects w1xbet 보너스 코드h schizophrenia including two multinational, six-week, randomized trials and a 52-week randomized maintenance trial.
The EMA is anticipated to complete 1xbet 보너스 코드s review in the second quarter of 2018.
Schizophrenia is a chronic, severe and disabling brain cond1xbet 보너스 코드ion. Typically, symptoms are first seen in adults younger than 30 years of age and include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or w1xbet 보너스 코드hdrawn. In Europe, 1xbet 보너스 코드 is estimated that there are about 5 million people w1xbet 보너스 코드h schizophrenia, w1xbet 보너스 코드h a prevalence of 0.6-0.8%.
Brexpiprazole was approved by the U.S. Food and Drug Administration in July 2015 to treat patients w1xbet 보너스 코드h schizophrenia (as well as an adjunctive treatment of major depressive disorder (MDD)). Brexpiprazole was also approved in February 2017 by Health Canada for the treatment of schizophrenia. In both countries brexpiprazole is distributed and marketed under the brand name REXULTI. If the EMA grants regulatory approval to brexpiprazole, the brand name of the product in the EU would be RXULTI®.