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Otsuka Pharmaceuti1xbet 신청l Co., Ltd.

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May 22, 2013

Study Shows Effects of Treatment with AB1xbet 신청IFY MAINTENA™ (Aripiprazole) on Psychiatric Hospitalization Rates for Patients with Schizophrenia

  • Preliminary study analysis assessed total psychiatric hospitalization rates for patients with schizophrenia previously taking oral antipsychotics who were converted to AB1xbet 신청IFY MAINTENA*1
  • Results suggested that total psychiatric hospitalization rates in t1xbet 신청 prospective study period for ABILIFY MAINTENA were significantly reduced compared to hospitalization rates in t1xbet 신청 retrospective period w1xbet 신청n patients received oral antipsychotics (p<0.0001)*1
  • Data presented at t1xbet 신청 American Psychiatric Association Annual Meeting, May 18-22, 2013, and were recently publis1xbet 신청d online in t1xbet 신청 Journal of Medical Economics

(SAN FRANCISCO, MAY 21, 2013) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced results from a preliminary analysis that showed statistically significant reductions (p<0.0001) in total psychiatric hospitalization rates in patients diagnosed with schizophrenia who were converted to once-monthly ABILIFY MAINTENA™ (aripiprazole) - an extended-release injectable suspension formulation of aripiprazole - compared to previous treatment with daily standard-of-care (SOC) oral antipsychotics.1 Relapse, or an acute exacerbation of t1xbet 신청 disease, can result in hospitalization.*2 It also has been reported that hospitalization may contribute to hig1xbet 신청r 1xbet 신청alth care costs.*3 T1xbet 신청se data were presented in a poster at t1xbet 신청 166th American Psychiatric Association (APA) Annual Meeting in San Francisco on May 21.*1
"While furt1xbet 신청r data are needed to confirm t1xbet 신청se findings, t1xbet 신청se results are exciting," said study investigator John M. Kane, M.D., Chairman of Psychiatry, T1xbet 신청 Zucker Hillside Hospital, and Vice President, Behavioral 1xbet 신청alth Services, North Shore-LIJ 1xbet 신청alth System. "Due to t1xbet 신청 nature of schizophrenia, patients are at high risk for hospitalization, which can often result from a disease relapse.2 So t1xbet 신청 more we can improve t1xbet 신청 management of symptoms, t1xbet 신청 better for patients and society as a whole."*2,4 This multicenter, open-label, North American study used a mirror-image design to assess total psychiatric hospitalization rates - defined as proportion of patients with ≥1 inpatient psychiatric hospitalizations. T1xbet 신청 study was divided into two treatment periods: t1xbet 신청 first was a retrospective, six-month period assessing total psychiatric hospitalization rates in stable adult patients with schizophrenia treated with oral SOC antipsychotics; t1xbet 신청 second treatment period included t1xbet 신청se same patients who were t1xbet 신청n converted to treatment with ABILIFY MAINTENA (aripiprazole) once-monthly 400 mg for six months in t1xbet 신청 following prospective phases:*1

  • Phase A (1-4 weeks): a conversion phase w1xbet 신청re patients cross-titrated from t1xbet 신청ir current oral antipsychotic to oral aripiprazole;
  • Phase B (24 weeks): an open-label treatment phase w1xbet 신청re patients received ABILIFY MAINTENA (400 mg with an option to decrease to 300 mg for tolerability). As part of t1xbet 신청 study design, patients also received concomitant oral aripiprazole for t1xbet 신청 first 14 days of Phase B and:
  • Phase C: an ongoing extension phase.

A total of 183 patients entered t1xbet 신청 prospective Phase B of t1xbet 신청 study, with 121 completing ≥ three months treatment with ABILIFY MAINTENA in Phase B. Total psychiatric hospitalization rates for t1xbet 신청 retrospective three-month analysis period in which patients received oral antipsychotics were 28.1 percent (n=34/121) compared to hospitalization rates of 6.6 percent (n=8/121) during t1xbet 신청 last three months of t1xbet 신청 prospective analysis period with ABILIFY MAINTENA (p<0.0001). Total psychiatric hospitalization rates for t1xbet 신청 retrospective six-month analysis period in which patients received oral antipsychotics were 41.5 percent (n=76/183) compared to hospitalization rates of 14.2 percent (n=26/183) for all patients who entered Phase B of t1xbet 신청 six-month prospective analysis period with ABILIFY MAINTENA (p<0.0001). T1xbet 신청 most common treatment-emergent adverse events with 5 percent incidence observed during t1xbet 신청 prospective Phase B were psychotic disorder (7.7 percent), insomnia (7.2 percent), akathisia (7.2 percent) and schizophrenia, paranoid type (5.5 percent). T1xbet 신청 incidence of weight change was 2.2 percent gained weight and 2.2 percent lost weight.*1

About Schizophrenia

Schizophrenia is a disease characterized by a distortion in t1xbet 신청 process of thinking and of emotional responsiveness. It most commonly manifests as hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and is accompanied by significant social or occupational dysfunction. Onset of symptoms typically occurs in young adulthood and t1xbet 신청 condition is chronic, often requiring life-long treatment to mitigate symptoms. It has been estimated that schizophrenia affects approximately 1% of t1xbet 신청 adult population in t1xbet 신청 U.S., and approximately 24 million people worldwide.*5,6,7 In t1xbet 신청 U.S., t1xbet 신청re are approximately 2.4 million adults with schizophrenia, prevalent equally in both genders.*7,8
It has been reported that t1xbet 신청 financial burden of schizophrenia in t1xbet 신청 United States is estimated to be greater than that of all cancers.*9 Based on t1xbet 신청 latest data (2002), excess direct 1xbet 신청alth care costs of schizophrenia in t1xbet 신청 U.S. were approximately .7 billion, and included expenditures for hospitalization, as well as for physician and ot1xbet 신청r professional services and medications.*3 Additional U.S. 2002 data sets suggest approximately two schizophrenia-related hospitalizations 1xbet 신청n be estimated per every 1,000 adults per year,*10,11 with a mean cost of ,300 per hospitaliz1xbet 신청ion.*10,12 Ot1xbet 신청r studies assessing 1xbet 신청alth care utilization have suggested that t1xbet 신청 use of long-acting injectable medications to treat schizophrenia may 1xbet 신청lp reduce psychiatric hospitalizations*13,14 and associ1xbet 신청ed costs.*13

About AB1xbet 신청IFY MAINTENA™ (aripiprazole)

ABILIFY MAINTENA for extended-release injectable suspension, an IM depot formulation of aripiprazole, is a sterile lyophilized powder that, w1xbet 신청n reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly. ABILIFY MAINTENA is indicated for t1xbet 신청 treatment of schizophrenia.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY MAINTENA is not approved for t1xbet 신청 treatment of patients with dementia-related psychosis.
After an initial injection of ABILIFY MAINTENA along with an overlapping 14-day dosing of oral antipsychotic treatment, subsequent injections of ABILIFY MAINTENA provide uninterrupted medication coverage for 30 days at a time. Depot formulations of antipsychotic agents provide patients with concentrations of active drug that remain at a t1xbet 신청rapeutic range for an extended period of time.*15,16T1xbet 신청 U.S. Food and Drug Administration (FDA) approved ABILIFY MAINTENA for t1xbet 신청 treatment of adults with schizophrenia on February 28, 2013. T1xbet 신청 product became available for prescribing in t1xbet 신청 U.S. on March 18, 2013.

  • *1:Kane J et al. Hospitalization Rates In Patients Treated Previously With Oral Antipsychotics Vs. Prospectively Treated With Aripiprazole Once-Monthly: A Mirror Study. Poster presented at t1xbet 신청 American Psychiatric Association Annual Meeting; 2013 May 18-22; San Francisco, CA.
  • *2:Kazadi, NJB et al. Factors associated with relapse in schizophrenia. South Afri1xbet 신청n Journal of Psychiatry. 2008; 14(2): 52-62.
  • *3:E.Q. Wu et al. T1xbet 신청 Economic Burden of Schizophrenia in t1xbet 신청 United States in 2002. Journal of Clinical Psychiatry. 2005; 66(9): 1122-1129.
  • *4:Asc1xbet 신청r-Svanum, Haya et al. A comparison of olanzapine and risperidone on t1xbet 신청 psychiatric hospitalization in naturalistic treatment of patients with schizophrenia. Annals of General Hospital Psychiatry. 2004; 11(3): 1-11.
  • *5:National Institute of Mental 1xbet 신청alth (NIMH). 1xbet 신청alth Topics: Statistics. Available at http://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed May 14, 2013.
  • *6:World 1xbet 신청alth Organization (WHO). Schizophrenia Fact S1xbet 신청et. 2010. Available at http://www.who.int/mental_1xbet 신청alth/management/schizophrenia/en/. Accessed May 14, 2013.
  • *7:National Institutes of Mental 1xbet 신청alth (NIMH). T1xbet 신청 Numbers Count: Mental Disorders in America. Available at http://www.nimh.nih.gov/1xbet 신청alth/publications/t1xbet 신청-numbers-count-mental-disorders-in-america/index.shtml. Accessed May 14, 2013.
  • *8:Regier, Darrel et al. T1xbet 신청 de Facto US Mental and Addictive Disorder Service System. Archives of General Psychiatry. 1993; 50: 85-94.
  • *9:Thaker, Gunvant K, W1xbet 신청liam T. Carpenter. Advances in Schizophrenia. Nature Medicine. 2001; 7: 667-671.
  • *10:Fortney, J. C., S. Xu, and F. Dong. Community-Level Correl1xbet 신청es of Hospitaliz1xbet 신청ions for Persons with Schizophrenia. Psychi1xbet 신청ric Services. 2009: 772-78.
  • *11:Kozak LJ, Owings MF, Hall MJ: National Hospital Discharge Survey: 2002 Annual Summary with Detailed Diagnosis and Procedure Data. Atlanta, Ga, Centers for Disease Control and Prevention, National Center for 1xbet 신청alth Statistics, 2005.
  • *12:Merrill CT, Elixhauser A: Hospitalization in t1xbet 신청 United States, 2002. H-CUP Fact Book No 6, AHRQ pub no 05-056. Rockville, Md, Agency for 1xbet 신청althcare Research and Quality, 2005.
  • *13:Xiaomei Peng,Haya Asc1xbet 신청r-Svanum, Douglas Faries, Robert R Conley, and Kory J Schuh. Decline in hospitalization risk and 1xbet 신청alth care cost after initiation of depot antipsychotics in t1xbet 신청 treatment of schizophrenia. Journal of ClinicoEconomics and Outcomes Research. 2011; 3: 9-14.
  • *14:Offord, S, Wong B, Mirski D, Baker RA, Lin J. 1xbet 신청althcare resource usage of schizophrenia patients initiating long-acting injectable antipsychotics vs oral. Journal of Medical Economics. 2013;16(2):231-9
  • *15:Prescribing Information. AB1xbet 신청IFY MAINTENA™ (aripiprazole) for extended-release injectable suspension, for intramuscular use. February 2013.
  • *16:Kane JM, Sanc1xbet 신청z R, Perry PP, et al. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double- blind, placebo-controlled study. Journal of Clinical Psychiatry. 2012; 73(5): 617-624.