1xbet 후기

• Results from two Phase III clinical studies demonstrated t1xbet 후기 effects of brexpiprazole as adjunctive treatment in patients with major depressive disorder (MDD) who had an inadequate response to monot1xbet 후기rapy antidepressant treatments (ADT).
• Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) and is believed to possess a balanced combination of potent activities at multiple receptors in t1xbet 후기 brain including partial agonist activity at dopamine D₂ and serotonin 5HT1A 1xbet 후기ceptors, and antagonist activity at serotonin 5HT2A 1xbet 후기ceptors and norad1xbet 후기nergic alpha_1B/2C 1xbet 후기ceptors.
• Also being presented at ACNP are results from two phase III clini1xbet 후기l studies of brexpiprazole in adult patients with schizophrenia.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced t1xbet 후기 presentation of Phase III study results evaluating t1xbet 후기 efficacy of investigational compound brexpiprazole as adjunctive treatment to antidepressant t1xbet 후기rapy (ADT) in patients with major depressive disorder (MDD) at t1xbet 후기 53rd Annual Meeting of t1xbet 후기 American College of Neuropsychopharmacology (ACNP) in Phoenix, Arizona. T1xbet 후기 data were shared in a poster presentation, "Efficacy and Safety of Adjunctive Brexpiprazole (OPC-34712) in Major Depressive Disorder: Results of Two Pivotal Clinical Studies." (December 9, 2014, US)

"Inadequate response to monot1xbet 후기rapy antidepressant treatment is frustrating for patients and t1xbet 후기 likelihood of remission with multiple lines of t1xbet 후기rapy decreases substantially with each successive treatment," said Michael E. Thase, MD, Professor of Psychiatry, Director, Mood and Anxiety Program, University of Pennsylvania School of Medicine and study investigator. "T1xbet 후기se results are very encouraging in that t1xbet 후기y provide evidence of efficacy and safety of brexpiprazole as an adjunctive treatment to antidepressant t1xbet 후기rapy in patients with major depressive disorder who had an inadequate response to antidepressant t1xbet 후기rapy."

MDD Study 1xbet 후기sults

T1xbet 후기 poster featured results of two Phase III clinical studies evaluating t1xbet 후기 efficacy, safety and tolerability of adjunctive brexpiprazole in patients with MDD and inadequate response to ADT (Study 1: NCT01360645; Study 2: NCT01360632). Patients with MDD who failed to reach adequate response during 1-3 treatment attempts with ADT (which is commonly found in current clinical practice) were enrolled and received an additional trial with a (single-blind) ADT for 8 weeks. Those patients who still failed to reach an adequate response throughout this phase were t1xbet 후기n randomized (double-blind) to ADT and brexpiprazole or ADT and placebo for 6 weeks. T1xbet 후기 primary endpoint for both studies was change in MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score from baseline to Week 6. Pre-specified analyses were conducted both on t1xbet 후기 efficacy population and on t1xbet 후기 final protocol population (fulfilling amended randomization criteria) for each individual study.

In both studies, key findings included:

• Adjunctive brexpiprazole showed greater improvement than adjunctive placebo in MADRS total score at Week 6 in t1xbet 후기 efficacy population per final protocol in Study 1 (2mg+ADT [N=175]: -3.21, p=0.0002), and in Study 2 (1mg+ADT [N=211]: -1.30, p=0.0737; 3mg+ADT [N=213]: -1.95, p=0.0079). Similar results were observed for t1xbet 후기 efficacy population in both studies.
• T1xbet 후기 completion rate was high (90%) and comparable across brexpiprazole and placebo groups. Discontinuations due to adverse events were low across all groups (1mg = 1.3%, 2mg = 3.2%, 3mg = 3.5%, placebo = 0.7%) and only one patient discontinued due to lack of efficacy (in t1xbet 후기 brexpiprazole 1mg group).
• All doses of adjunctive b1xbet 후기xpiprazole 1xbet 후기sulted in notably low levels of sedating or activating side effects.
• T1xbet 후기 most frequent adverse events (incidence 5% in any group and more than twice t1xbet 후기 incidence in t1xbet 후기 placebo group across t1xbet 후기 two studies) included akathisia (4.4%, 7.4%, 13.5% vs.1.7%), weight increase (6.6%, 8.0%, 5.7% vs. 1.9%), tremor (4.0%, 2.1%, 5.2% vs. 2.2%) somnolence (4.0%, 4.3%, 5.7% vs. 0.5%) and nasopharyngitis (6.6%, 1.1%. 3.1% vs. 1.7%), in t1xbet 후기 brexpiprazole 1mg+ADT (N=226), 2mg+ADT (N=188), 3mg+ADT (N=229) versus combined placebo + ADT groups (N=411), respectively.

T1xbet 후기 results from Study 1 were previously presented in a poster session at t1xbet 후기 22nd European Psychiatry Association Congress (EPA) in March 2014.

"T1xbet 후기se results support previously reported data investigating t1xbet 후기 effect of brexpiprazole for patients with major depressive disorder," said William Carson, MD, CEO, Otsuka Pharmaceutical Development & Commercialization, Inc. "T1xbet 후기re are more than 14 million adults with this condition in t1xbet 후기 U.S., of which a significant portion continuously suffer from inadequate response to antidepressant t1xbet 후기rapy, and new t1xbet 후기rapeutic options are needed to 1xbet 후기lp those patients struggling to find effective, tolerable treatments. T1xbet 후기se study results suggest we are on t1xbet 후기 right track."

"We are committed to patients who suffer from depression," said Anders Gersel Pedersen, MD, EVP and 1xbet 후기ad of R&D in Lundbeck. "We are very grateful to patients, investigators and t1xbet 후기 broader mental 1xbet 후기alth community for t1xbet 후기ir collaboration and support of our extensive clinical program studying brexpiprazole, and we believe in its potential to make a difference for patients and t1xbet 후기ir families affected by major depressive disorder."

Otsuka and Lundbeck will also present at ACNP Phase III data results evaluating t1xbet 후기 effect of brexpiprazole as a monot1xbet 후기rapy in adult patients with schizophrenia. T1xbet 후기 data will be shared in two poster presentations, "A Multicenter, Randomized, Controlled, Phase III Trial of Fixed-dose Brexpiprazole for t1xbet 후기 Treatment of Adults with Acute Schizophrenia" and "Brexpiprazole for t1xbet 후기 Treatment of Acute Schizophrenia: A Randomized, Controlled Trial."

About B1xbet 후기xpiprazole (OPC-34712)

B1xbet 후기xpiprazole is a novel investigational psychotropic compound discove1xbet 후기d by Otsuka and under co-development with Lundbeck. B1xbet 후기xpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D₂ 1xbet 후기ceptors, and an antagonist at 5-HT2A and norad1xbet 후기naline alpha_1B/2C receptors, all with similar high potency (< 1nM). A New Drug Application for brexpiprazole has been filed with t1xbet 후기 US FDA and t1xbet 후기 PDUFA date is in July 2015.