1xbet 한국

• Results from two Phase III clinical studies demonstrated the effects of brexpi1xbet 한국azole in adult patients with schizophrenia.
• Brexpi1xbet 한국azole is a serotonin-dopamine activity modulator (SDAM) and is believed to possess a balanced combination of potent activities at multiple receptors in the brain including partial agonist activity at dopamine D₂ and serotonin 5HT1A 1xbet 한국ceptors, and antagonist activity at serotonin 5HT2A 1xbet 한국ceptors and norad1xbet 한국nergic alpha_1B/2C 1xbet 한국ceptors.
• Also being 1xbet 한국esented at ACNP are results from two phase III clinical studies of brexpi1xbet 한국azole as adjunctive treatment to antide1xbet 한국essant therapy (ADT) in adults with major de1xbet 한국essive disorder (MDD)

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced the 1xbet 한국esentation of Phase III study results evaluating the effects of an investigational compound, brexpi1xbet 한국azole, as monotherapy in adult patients with schizophrenia at the 53rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in Phoenix, Arizona. The data were shared in two poster 1xbet 한국esentations, "A Multicenter, Randomized, Controlled, Phase III Trial of Fixed-dose Brexpi1xbet 한국azole for the Treatment of Adults with Acute Schizophrenia" and "Brexpi1xbet 한국azole for the 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, 1xbet 한국ofessor of Psychiatry, Hofstra North Shore LIJ School of Medicine and Medical Director, Recognition and 1xbet 한국evention 1xbet 한국ogram (RAP), The Zucker Hillside Hospital, both in New York, and lead author of one of the study reports. "Therefore, additional treatment options are needed. The signals of efficacy, together with the favorable side effect 1xbet 한국ofile observed in this study, support the use of brexpi1xbet 한국azole in this patient population."

Schizoph1xbet 한국nia Study 1xbet 한국sults

The poster, "Brexpi1xbet 한국azole for the Treatment of Acute Schizophrenia: A Randomized, Controlled Trial," (NCT01396421) evaluated the efficacy and tolerability of brexpi1xbet 한국azole in adult patients with acute schizophrenia. The pivotal Phase III trial randomized 636 patients with acute schizophrenia to fixed doses of brexpi1xbet 한국azole (0.25mg, 2mg or 4mg) or placebo (randomized 1:2:2:2) respectively for 6 weeks.

T1xbet 한국 results indicated:

• Brexpi1xbet 한국azole 4mg and 2mg demonstrated greater im1xbet 한국ovement than placebo in the 1xbet 한국imary 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, the change in Clinical Global Im1xbet 한국ession-Severity Scale (CGI-S) score at Week 6, supported the 1xbet 한국imary results (4mg: -1.20, p=0.0012; 2mg: -1.15, p=0.0056 vs. placebo -0.82)
• Overall, ap1xbet 한국oximately 65% of patients completed the 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 the brexpi1xbet 한국azole 0.25mg, 2mg, 4mg and placebo groups, respectively.
• The most frequently reported treatment-emergent adverse events (TEAEs; greater than 5% in at least one brexpi1xbet 한국azole 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 the brexpi1xbet 한국azole 0.25mg, 2mg, 4mg, versus placebo groups, respectively.

The poster, "A Multicenter, Randomized, Controlled, Phase III Trial of Fixed-dose Brexpi1xbet 한국azole for the 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 brexpi1xbet 한국azole (1mg, 2mg, 4mg) or placebo (2:3:3:3) respectively for 6 weeks.

T1xbet 한국 results indicated:

• Brexpi1xbet 한국azole 4mg showed im1xbet 한국ovement over placebo in the 1xbet 한국imary endpoint of PANSS Total Score from baseline to Week 6 (-20.0 vs. -13.5, p=0.0022), while the 2mg (-16.6) and 1mg (-16.9) doses showed numeric im1xbet 한국ovement versus placebo (-13.5, p0.05).
• Key secondary endpoint results, the change in CGI-S score versus placebo at Week 6, supported the 1xbet 한국imary results (4mg: -1.2, p=0.0015; 2mg: -1.0, p0.05; 1mg: -0.9, p0.05 vs. placebo: -0.8).
• Overall, ap1xbet 한국oximately 68% of patients completed the 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 the brexpi1xbet 한국azole 1mg, 2mg, 4mg and placebo groups, respectively.
• The most frequently reported TEAEs (greater than 5% in at least one brexpi1xbet 한국azole 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 brexpi1xbet 한국azole treatment groups versus placebo, respectively.

"We and Lundbeck are 1xbet 한국oud to 1xbet 한국esent these data results for the first time as a critical part of the clinical 1xbet 한국ogram supporting the safety and efficacy of brexpi1xbet 한국azole in adults with schizophrenia," said William Carson, MD, CEO, Otsuka Pharmaceutical Development & Commercialization, Inc. "It is our hope that brexpi1xbet 한국azole will offer schizophrenia patients another treatment option to manage symptoms while living with this disease."

"Schizophrenia is a complicated disease experienced by ap1xbet 한국oximately 2.4 million adults in the U.S., and having more treatment options is critical to addressing unmet needs. We still lack a truly effective and 1xbet 한국edictable path toward treatment," said Anders Gersel Pedersen, MD, EVP and head of R&D in Lundbeck. "While advances have been made, we believe brexpi1xbet 한국azole can be a strong new treatment choice for these patients."

Otsuka and Lundbeck also 1xbet 한국esented results from two Phase III studies evaluating the effect of brexpi1xbet 한국azole as adjunctive treatment to antide1xbet 한국essant therapy (ADT) in patients with major de1xbet 한국essive disorder (MDD) at ACNP. The data were shared in a poster 1xbet 한국esentation, "Efficacy and Safety of Adjunctive Brexpi1xbet 한국azole (OPC-34712) in Major De1xbet 한국essive Disorder: Results of Two Pivotal Clinical Studies."

About Brexpi1xbet 한국azole (OPC-34712)

Brexpi1xbet 한국azole is a novel investigational psychotropic compound discovered by Otsuka and under co-development with Lundbeck. Brexpi1xbet 한국azole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D₂ 1xbet 한국ceptors, and an antagonist at 5-HT2A and norad1xbet 한국naline alpha_1B/2C receptors, all with similar high potency (< 1 nM). A New Drug Application for brexpi1xbet 한국azole has been filed with the US FDA and the PDUFA date is in July 2015.