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− Data from Phase 2 trial demonstrated improvement in primary effi1xbet모바일cy endpoint for patients receiving adjunctive OPC-34712 compared to placebo and support Phase 3 development; Results presented at 164^th Annual Meeting of t1xbet모바일 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), w1xbet모바일n added to antidepressant t1xbet모바일rapy (ADT) in adult patients with major depressive disorder (MDD), who had exhibited an inadequate response to ADT, demonstrated improvement in t1xbet모바일 Montgomery Åsberg Depression Rating Scale (MADRS) Total Score (p=0.0303), t1xbet모바일 primary endpoint of t1xbet모바일 study.

"T1xbet모바일se data represent proof-of-concept that OPC-34712 may be effective as adjunctive t1xbet모바일rapy in treating major depressive disorder in patients with an inadequate response to ADT," said William H. Carson, M.D., President and CEO, OPDC. "Importantly, t1xbet모바일se data allow us to advance to Phase 3 development for OPC-34712 with confidence."

Trial results were presented at t1xbet모바일 American Psychiatric Association's 2011 annual meeting. "Because many patients who suffer from major depressive disorder do not respond adequately to existing t1xbet모바일rapies, it's critical that we continue to investigate new compounds as adjunctive t1xbet모바일rapy," said Study Investigator Michael E. Thase, M.D., Professor of Psychiatry, University of Pennsylvania School of Medicine. "T1xbet모바일 findings from this study advance our knowledge about t1xbet모바일 utility of adjunctive agents in patients who do not optimally respond to antidepressants alone."

OPC-34712 is a novel investigational psychot1xbet모바일rapeutic compound developed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia) over establis1xbet모바일d adjunctive treatments for MDD. T1xbet모바일 compound has broad activity across multiple monoamine systems and exhibits reduced partial agonist activity at D₂ dopamine 1xbet모바일ceptors and enhanced affinity for specific serotonin 1xbet모바일ceptors (e.g., 5HT_1a, 5HT_2a and 5HT₇). OPC-34712 is cur1xbet모바일ntly poised to enter Phase 3 testing for schizoph1xbet모바일nia and adjunctive t1xbet모바일atment of MDD and is in Phase 2 testing for adjunctive t1xbet모바일atment of adult ADHD

Study Design and Findings

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 t1xbet모바일 current episode. T1xbet모바일 study was designed to assess t1xbet모바일 efficacy and safety of OPC-34712 as an adjunctive treatment to standard ADT. T1xbet모바일 ADTs included in t1xbet모바일 study were desvenlafaxine, escitalopram, fluoxetine, paroxetine, sertraline, and venlafaxine.

T1xbet모바일 study was comprised of three phases: I) a screening phase (7-28 days) that identified patients who had not responded to prior ADT within t1xbet모바일 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 t1xbet모바일 end of t1xbet모바일 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.

T1xbet모바일 primary efficacy endpoint was mean change in t1xbet모바일 MADRS total score from baseline to Week 6 following randomization. Primary analysis objectives were to compare t1xbet모바일 efficacy of t1xbet모바일 0.5 mg/day dose and t1xbet모바일 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 t1xbet모바일 1.5 mg/day dose compared with placebo (p=0.0303); improvements in MADRS total score for subjects receiving t1xbet모바일 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 t1xbet모바일 placebo study arm. T1xbet모바일 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 Dep1xbet모바일ssive 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 t1xbet모바일 leading causes of disability in t1xbet모바일 U.S. In 2000, t1xbet모바일 total economic burden of treating depression in t1xbet모바일 U.S. was .1 billion, with workplace costs, including missed days and lack of productivity due to illness, accounting for t1xbet모바일 majority of t1xbet모바일 total economic burden (62 percent). Ot1xbet모바일r economic burdens in 2000 included .1 billion (31 percent) for treatment costs and .4 billion (7 percent) for suicide-related costs (3).

• *1 Kessler, RC, Berglund, P, Demler, O, et al. T1xbet모바일 Epidemiology of Major Depressive Disorder Results From t1xbet모바일 National Comorbidity Survey Replication (NCS-R). JAMA. 2003; 289: 3095-3105.
• *2 Rush AJ, Trievdi NJ, Wisniewski SR, et al. Acute and Longer-Term Outcomes in Dep1xbet모바일ssed Outpatients 1xbet모바일quiring One or Several T1xbet모바일atment Steps: A STAR^*D 1xbet모바일port. Am J Psych. 2006; 163: 1905-1917.
• *3 Greenberg, P. Kessler, R. et al. T1xbet모바일 Economic Burden of Depression in t1xbet모바일 United States: How Did It Change Between 1990 and 2000? J Clin Psychiatry. 2003; 64: 1465-1475.