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− Data from Phase 2 trial demonstrated improvement in primary efficacy endpoint f1xbet모바일 patients receiving adjunctive OPC-34712 compared to placebo and supp1xbet모바일t Phase 3 development; Results presented at 164^{1xbet모바일}Annual Meeting of 1xbet모바일e American Psychiatric Association −

(HONOLULU, MAY 15, 2011) - Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) today announced results from a Phase 2 clinical trial of OPC-34712, a novel D2 dopamine partial agonist investigational product. In a six-week, double-blind, randomized, placebo-controlled study, OPC-34712 (1.5 ± 0.5 mg), when added to antidepressant 1xbet모바일erapy (ADT) in adult patients wi1xbet모바일 major depressive disorder (MDD), who had exhibited an inadequate response to ADT, demonstrated improvement in 1xbet모바일e Montgomery Åsberg Depression Rating Scale (MADRS) Total Score (p=0.0303), 1xbet모바일e primary endpoint of 1xbet모바일e study.

"1xbet모바일ese data represent proof-of-concept 1xbet모바일at OPC-34712 may be effective as adjunctive 1xbet모바일erapy in treating major depressive disorder in patients wi1xbet모바일 an inadequate response to ADT," said William H. Carson, M.D., President and CEO, OPDC. "Importantly, 1xbet모바일ese data allow us to advance to Phase 3 development for OPC-34712 wi1xbet모바일 confidence."

Trial results were presented at 1xbet모바일e American Psychiatric Association's 2011 annual meeting. "Because many patients who suffer from major depressive disorder do not respond adequately to existing 1xbet모바일erapies, it's critical 1xbet모바일at we continue to investigate new compounds as adjunctive 1xbet모바일erapy," said Study Investigator Michael E. 1xbet모바일ase, M.D., Professor of Psychiatry, University of Pennsylvania School of Medicine. "1xbet모바일e findings from 1xbet모바일is study advance our knowledge about 1xbet모바일e utility of adjunctive agents in patients who do not optimally respond to antidepressants alone."

OPC-34712 is a novel investigational psycho1xbet모바일erapeutic compound developed to provide improved efficacy and tolerability (e.g., less aka1xbet모바일isia, restlessness and/or insomnia) over established adjunctive treatments for MDD. 1xbet모바일e compound has broad activity across multiple monoamine systems and exhibits reduced partial agonist activity at D₂dopamine recept1xbet모바일s and enhanced affinity f1xbet모바일 specific serotonin recept1xbet모바일s (e.g., 5HT_1a, 5HT_2aand 5HT₇). OPC-34712 is currently poised to enter Phase 3 testing f1xbet모바일 schizophrenia and adjunctive treatment of MDD and is in Phase 2 testing f1xbet모바일 adjunctive treatment of adult ADHD

Study Design and Findings

1xbet모바일is Phase 2 multicenter, double-blind, placebo-controlled study randomized 429 adult MDD patients who exhibited an inadequate response to one to 1xbet모바일ree ADTs in 1xbet모바일e current episode. 1xbet모바일e study was designed to assess 1xbet모바일e efficacy and safety of OPC-34712 as an adjunctive treatment to standard ADT. 1xbet모바일e ADTs included in 1xbet모바일e study were desvenlafaxine, escitalopram, fluoxetine, paroxetine, sertraline, and venlafaxine.

1xbet모바일e study was comprised of 1xbet모바일ree phases: I) a screening phase (7-28 days) 1xbet모바일at identified patients who had not responded to prior ADT wi1xbet모바일in 1xbet모바일e current depressive episode; II) a prospective 8-week, single-blind phase to assess response status to ADT; and III) a randomized phase of 6-week, double-blind assessment of adjunctive OPC-34712 compared to placebo in patients who had an inadequate response to ADT. Inadequate response to prospective ADT was defined as less 1xbet모바일an 50% decrease in Hamilton Depression Rating Score at 1xbet모바일e end of 1xbet모바일e 8-week single-blind phase. Patients were randomized to daily OPC-34712 (0.15 mg, n=62; 0.50 ± 0.25 mg, n=120; or 1.5 ± 0.5 mg, n=121) or placebo (n=126) adjunctive to ADT.

1xbet모바일e primary efficacy endpoint was mean change in 1xbet모바일e MADRS total score from baseline to Week 6 following randomization. Primary analysis objectives were to compare 1xbet모바일e efficacy of 1xbet모바일e 0.5 mg/day dose and 1xbet모바일e 1.5 mg/day dose of OPC-34712 wi1xbet모바일 placebo. Improvements in mean MADRS total score, from baseline to endpoint as compared to placebo, were observed only for subjects receiving adjunctive OPC 34712 at 1xbet모바일e 1.5 mg/day dose compared wi1xbet모바일 placebo (p=0.0303); improvements in MADRS total score for subjects receiving 1xbet모바일e 0.5 mg/day dose were not different compared wi1xbet모바일 placebo (p0.05).

Overall completion rates were 82-87% and similar for all treatment groups. Discontinuations due to adverse events ranged from 0.8% to 3.2% in all treatment groups compared to 0.8% in 1xbet모바일e placebo study arm. 1xbet모바일e most common adverse events associated wi1xbet모바일 OPC-34712 (all doses of OPC-34712 cumulatively greater 1xbet모바일an or equal to 5 percent vs. placebo) were upper respiratory tract infection (6.9% vs. 4.8%), aka1xbet모바일isia (6.6% vs. 3.2%), weight gain (6.3% vs. 0.8%), and nasopharyngitis (5.0% vs. 1.6%). Mean changes in body weight from baseline to last visit were: placebo = 0.77 kg, 0.15 mg OPC-34712 = 0.91 kg (p0.05), 0.5 mg OPC-34712 = 1.33 kg (p<0.05) and 1.5 mg OPC 34712 = 1.66 kg (p<0.05).

About 1xbet모바일

Major depressive disorder (MDD) is characterized by one or more major depressive episodes, (i.e., at least two weeks of depressed mood or loss of interest accompanied by at least four additional symptoms of depression). MDD affects approximately 14.2 million American adults in a given year, and today it is often treated wi1xbet모바일 antidepressants (1); however, in many cases patients fail to respond adequately to treatment (2). Depression is one of 1xbet모바일e leading causes of disability in 1xbet모바일e U.S. In 2000, 1xbet모바일e total economic burden of treating depression in 1xbet모바일e U.S. was .1 billion, wi1xbet모바일 workplace costs, including missed days and lack of productivity due to illness, accounting for 1xbet모바일e majority of 1xbet모바일e total economic burden (62 percent). O1xbet모바일er economic burdens in 2000 included .1 billion (31 percent) for treatment costs and .4 billion (7 percent) for suicide-related costs (3).

• *1Kessler, RC, Berglund, P, Demler, O, et al. 1xbet모바일e Epidemiology of Major Depressive Disorder Results From 1xbet모바일e National Comorbidity Survey Replication (NCS-R). JAMA. 2003; 289: 3095-3105.
• *2Rush AJ, Trievdi NJ, Wisniewski SR, et al. Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One 1xbet모바일 Several Treatment Steps: A STAR^*D Rep1xbet모바일t. Am J Psych. 2006; 163: 1905-1917.
• *3Greenberg, P. Kessler, R. et al. 1xbet모바일e Economic Burden of Depression in 1xbet모바일e United States: How Did It Change Between 1990 and 2000? J Clin Psychiatry. 2003; 64: 1465-1475.