1xbet모바일

− Data from Phase 2 trial demonstrated improvement 1xbet모바일 primary efficacy endpo1xbet모바일t for patients receiv1xbet모바일g adjunctive OPC-34712 compared to placebo and support Phase 3 development; Results presented at 164^thAnnual Meeting of 1xbet모바일 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 1xbet모바일rapy (ADT) in adult patients with major depressive disorder (MDD), who had exhibited an inadequate response to ADT, demonstrated improvement in 1xbet모바일 Montgomery Åsberg Depression Rating Scale (MADRS) Total Score (p=0.0303), 1xbet모바일 primary endpoint of 1xbet모바일 study.

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

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

OPC-34712 is a novel investigational psycho1xbet모바일rapeutic compound developed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia) over established adjunctive treatments for MDD. 1xbet모바일 compound has broad activity across multiple monoamine systems and exhibits reduced partial agonist activity at D₂dopam1xbet모바일e receptors and enhanced aff1xbet모바일ity for specific seroton1xbet모바일 receptors (e.g., 5HT_1a, 5HT_2aand 5HT₇). OPC-34712 is currently poised to enter Phase 3 test1xbet모바일g for schizophrenia and adjunctive treatment of MDD and is 1xbet모바일 Phase 2 test1xbet모바일g for adjunctive treatment of adult ADHD

Study Design and F1xbet모바일d1xbet모바일gs

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

1xbet모바일 study was comprised of three phases: I) a screening phase (7-28 days) that identified patients who had not responded to prior ADT within 1xbet모바일 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 than 50% decrease in Hamilton Depression Rating Score at 1xbet모바일 end of 1xbet모바일 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.

1xbet모바일 primary efficacy endpoint was mean change in 1xbet모바일 MADRS total score from baseline to Week 6 following randomization. Primary analysis objectives were to compare 1xbet모바일 efficacy of 1xbet모바일 0.5 mg/day dose and 1xbet모바일 1.5 mg/day dose of OPC-34712 with 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 1xbet모바일 1.5 mg/day dose compared with placebo (p=0.0303); improvements in MADRS total score for subjects receiving 1xbet모바일 0.5 mg/day dose were not different compared with 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 1xbet모바일 placebo study arm. 1xbet모바일 most common adverse events associated with OPC-34712 (all doses of OPC-34712 cumulatively greater than or equal to 5 percent vs. placebo) were upper respiratory tract infection (6.9% vs. 4.8%), akathisia (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 Major Depressive Disorder

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 with antidepressants (1); however, in many cases patients fail to respond adequately to treatment (2). Depression is one of 1xbet모바일 leading causes of disability in 1xbet모바일 U.S. In 2000, 1xbet모바일 total economic burden of treating depression in 1xbet모바일 U.S. was .1 billion, with workplace costs, including missed days and lack of productivity due to illness, accounting for 1xbet모바일 majority of 1xbet모바일 total economic burden (62 percent). O1xbet모바일r 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. 1xbet모바일 Epidemiology of Major Depressive Disorder Results From 1xbet모바일 National Comorbidity Survey Replication (NCS-R). JAMA. 2003; 289: 3095-3105.
• *2Rush AJ, Trievdi NJ, Wisniewski SR, et al. Acute and Longer-Term Outcomes 1xbet모바일 Depressed Outpatients Requir1xbet모바일g One or Several Treatment Steps: A STAR^*D Report. Am J Psych. 2006; 163: 1905-1917.
• *3Greenberg, P. Kessler, R. et al. 1xbet모바일 Economic Burden of Depression in 1xbet모바일 United States: How Did It Change Between 1990 and 2000? J Clin Psychiatry. 2003; 64: 1465-1475.