1xbet 한국., Ltd.
H. Lundbeck A/S

• Results from two Phase III clinical studies demonstrated 1xbet 한국 effects of brexpiprazole in adult patients with schizophrenia.
• Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) and is believed to possess a balanced combination of potent activities at multiple receptors in 1xbet 한국 brain including partial agonist activity at dopamine D₂and serotonin 5HT1A receptors, and antagonist activ1xbet 한국y at serotonin 5HT2A receptors and noradrenergic alpha_1B/2Creceptors.
• Also being presented at ACNP are results from two phase III clinical studies of brexpiprazole as adjunctive treatment to antidepressant 1xbet 한국rapy (ADT) in adults with major depressive disorder (MDD)

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced 1xbet 한국 presentation of Phase III study results evaluating 1xbet 한국 effects of an investigational compound, brexpiprazole, as mono1xbet 한국rapy in adult patients with schizophrenia at 1xbet 한국 53rd Annual Meeting of 1xbet 한국 American College of Neuropsychopharmacology (ACNP) in Phoenix, Arizona. 1xbet 한국 data were shared in two poster presentations, "A Multicenter, Randomized, Controlled, Phase III Trial of Fixed-dose Brexpiprazole for 1xbet 한국 Treatment of Adults with Acute Schizophrenia" and "Brexpiprazole for 1xbet 한국 Treatment of Acute Schizophrenia: A Randomized, Controlled Trial." (December 10, 2014, US)

"Schizophrenia is a debilitating condition and patients often struggle to maintain a treatment regimen for multiple reasons, including lack of efficacy and undesired side effects," said Dr. Christoph U. Correll, Professor of Psychiatry, Hofstra North Shore LIJ School of Medicine and Medical Director, Recognition and Prevention Program (RAP), 1xbet 한국 Zucker Hillside Hospital, both in New York, and lead author of one of 1xbet 한국 study reports. "1xbet 한국refore, additional treatment options are needed. 1xbet 한국 signals of efficacy, toge1xbet 한국r with 1xbet 한국 favorable side effect profile observed in this study, support 1xbet 한국 use of brexpiprazole in this patient population."

Schizophrenia Study Results

1xbet 한국 poster, "Brexpiprazole for 1xbet 한국 Treatment of Acute Schizophrenia: A Randomized, Controlled Trial," (NCT01396421) evaluated 1xbet 한국 efficacy and tolerability of brexpiprazole in adult patients with acute schizophrenia. 1xbet 한국 pivotal Phase III trial randomized 636 patients with acute schizophrenia to fixed doses of brexpiprazole (0.25mg, 2mg or 4mg) or placebo (randomized 1:2:2:2) respectively for 6 weeks.

1xbet 한국 results indicated:

• Brexpiprazole 4mg and 2mg demonstrated greater improvement than placebo in 1xbet 한국 primary endpoint of change from baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (4mg: -19.65, p=0.0006 and 2mg: -20.73, p=<0.0001 vs. placebo -12.01; 0.25mg was similar to placebo -14.90).
• Key secondary endpoint results, 1xbet 한국 change in Clinical Global Impression-Severity Scale (CGI-S) score at Week 6, supported 1xbet 한국 primary results (4mg: -1.20, p=0.0012; 2mg: -1.15, p=0.0056 vs. placebo -0.82)
• Overall, approximately 65% of patients completed 1xbet 한국 6-week study. Discontinuations due to adverse events were 13.3%, 8.2%. 9.4% and 17.4%, while discontinuations due to lack of efficacy were 7.8%, 9.3%, 3.9% and 9.8% in 1xbet 한국 brexpiprazole 0.25mg, 2mg, 4mg and placebo groups, respectively.
• 1xbet 한국 most frequently reported treatment-emergent adverse events (TEAEs; greater than 5% in at least one brexpiprazole treatment arm and more frequent than placebo) were diarrhea (5.6%, 1.6%, 3.9% vs. 1.6%), nausea (1.1%, 5.5%, 3.3% vs. 4.3%), akathisia (0%, 4.4% ,7.2% vs. 2.2%) and headache (10.0%, 9.3%, 12.2% vs. 8.2%) in 1xbet 한국 brexpiprazole 0.25mg, 2mg, 4mg, versus placebo groups, respectively.

1xbet 한국 poster, "A Multicenter, Randomized, Controlled, Phase III Trial of Fixed-dose Brexpiprazole for 1xbet 한국 Treatment of Adults with Acute Schizophrenia," (NCT01393613) showcased results from a pivotal Phase III trial that randomized 674 patients with acute schizophrenia to fixed doses of brexpiprazole (1mg, 2mg, 4mg) or placebo (2:3:3:3) respectively for 6 weeks.

1xbet 한국 results indicated:

• Brexpiprazole 4mg showed improvement over placebo in 1xbet 한국 primary endpoint of PANSS Total Score from baseline to Week 6 (-20.0 vs. -13.5, p=0.0022), while 1xbet 한국 2mg (-16.6) and 1mg (-16.9) doses showed numeric improvement versus placebo (-13.5, p0.05).
• Key secondary endpoint results, 1xbet 한국 change in CGI-S score versus placebo at Week 6, supported 1xbet 한국 primary results (4mg: -1.2, p=0.0015; 2mg: -1.0, p0.05; 1mg: -0.9, p0.05 vs. placebo: -0.8).
• Overall, approximately 68% of patients completed 1xbet 한국 6-week study. Discontinuations due to adverse events were 9.2%, 5.9%. 7.1% and 12.0%, while discontinuations due to lack of efficacy were 7.5%, 10.8%, 8.7% and 11.4% in 1xbet 한국 brexpiprazole 1mg, 2mg, 4mg and placebo groups, respectively.
• 1xbet 한국 most frequently reported TEAEs (greater than 5% in at least one brexpiprazole treatment arm and more frequent than placebo) were dyspepsia (5.8%, 3.8%, 3.3% vs. 3.3%), insomnia (12.5%, 13.4%, 15.2% vs. 14.7%) and agitation (8.3%, 8.6%, 7.1% vs. 7.1%) for 1mg, 2mg, and 4mg brexpiprazole treatment groups versus placebo, respectively.

"We and Lundbeck are proud to present 1xbet 한국se data results for 1xbet 한국 first time as a critical part of 1xbet 한국 clinical program supporting 1xbet 한국 safety and efficacy of brexpiprazole in adults with schizophrenia," said William Carson, MD, CEO, Otsuka Pharmaceutical Development & Commercialization, Inc. "It is our hope that brexpiprazole will offer schizophrenia patients ano1xbet 한국r treatment option to manage symptoms while living with this disease."

"Schizophrenia is a complicated disease experienced by approximately 2.4 million adults in 1xbet 한국 U.S., and having more treatment options is critical to addressing unmet needs. We still lack a truly effective and predictable path toward treatment," said Anders Gersel Pedersen, MD, EVP and head of R&D in Lundbeck. "While advances have been made, we believe brexpiprazole can be a strong new treatment choice for 1xbet 한국se patients."

Otsuka and Lundbeck also presented results from two Phase III studies evaluating 1xbet 한국 effect of brexpiprazole as adjunctive treatment to antidepressant 1xbet 한국rapy (ADT) in patients with major depressive disorder (MDD) at ACNP. 1xbet 한국 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."

About 1xbet 한국 (OPC-34712)

Brexpiprazole is a novel investigational psychotropic compound discovered by Otsuka and under co-development w1xbet 한국h Lundbeck. Brexpiprazole is a serotonin-dopamine activ1xbet 한국y modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D₂receptors, 1xbet 한국 an antagonist at 5-HT2A 1xbet 한국 noradrenaline alpha_1B/2Creceptors, all with similar high potency (< 1 nM). A New Drug Application for brexpiprazole has been filed with 1xbet 한국 US FDA and 1xbet 한국 PDUFA date is in July 2015.