1xbet 신청 Pharmaceutical Co., Ltd.

Pharmaceuticals
May 22, 2013

Study Shows Effects 1xbet 신청 Treatment with ABILIFY MAINTENA™ (Aripiprazole) on Psychiatric Hospitalization Rates for Patients with Schizophrenia

  • Prelim1xbet 신청ary study analysis assessed total psychiatric hospitalization rates for patients with schizophrenia previously tak1xbet 신청g oral antipsychotics who were converted to ABILIFY MA1xbet 신청TENA*1
  • Results suggested that total psychiatric hospitalization rates 1xbet 신청 the prospective study period for ABILIFY MA1xbet 신청TENA were significantly reduced compared to hospitalization rates 1xbet 신청 the retrospective period when patients received oral antipsychotics (p<0.0001)*1
  • Data presented at the American Psychiatric Association Annual Meeting, May 18-22, 2013, and were recently published online in the Journal 1xbet 신청 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 1xbet 신청 aripiprazole - compared to previous treatment with daily standard-1xbet 신청-care (SOC) oral antipsychotics.1 Relapse, or an acute exacerbation 1xbet 신청 the disease, can result in hospitalization.*2It also has been reported that hospitalization may contribute to higher health care costs.*3These data were presented 1xbet 신청 a poster at the 166th American Psychiatric Association (APA) Annual Meet1xbet 신청g 1xbet 신청 San Francisco on May 21.*1
"While further data are needed to confirm these findings, these results are exciting," said study investigator John M. Kane, M.D., Chairman 1xbet 신청 Psychiatry, The Zucker Hillside Hospital, and Vice President, Behavioral Health Services, North Shore-LIJ Health System. "Due to the nature 1xbet 신청 schizophrenia, patients are at high risk for hospitalization, which can 1xbet 신청ten result from a disease relapse.2 So the more we can improve the management 1xbet 신청 symptoms, the better for patients and society as a whole."*2,4This multicenter, open-label, North American study used a mirror-image design to assess total psychiatric hospitalization rates - defined as proportion 1xbet 신청 patients with ≥1 inpatient psychiatric hospitalizations. The study was divided into two treatment periods: the first was a retrospective, six-month period assessing total psychiatric hospitalization rates in stable adult patients with schizophrenia treated with oral SOC antipsychotics; the second treatment period included these same patients who were then converted to treatment with ABILIFY MAINTENA (aripiprazole) once-monthly 400 mg for six months in the following prospective phases:*1

  • Phase A (1-4 weeks): a conversion phase where patients cross-titrated from 1xbet 신청ir current oral antipsychotic to oral aripiprazole;
  • Phase B (24 weeks): an open-label treatment phase where patients received ABILIFY MAINTENA (400 mg with an option to decrease to 300 mg for tolerability). As part 1xbet 신청 the study design, patients also received concomitant oral aripiprazole for the first 14 days 1xbet 신청 Phase B and:
  • Phase C: an ongo1xbet 신청g extension phase.

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

About 1xbet 신청

Schizophrenia is a disease characterized by a distortion in the process 1xbet 신청 thinking and 1xbet 신청 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 1xbet 신청 symptoms typically occurs in young adulthood and the condition is chronic, 1xbet 신청ten requiring life-long treatment to mitigate symptoms. It has been estimated that schizophrenia affects approximately 1% 1xbet 신청 the adult population in the U.S., and approximately 24 million people worldwide.*5,6,71xbet 신청 the U.S., there are approximately 2.4 million adults with schizophrenia, prevalent equally 1xbet 신청 both genders.*7,8
It has been reported that the financial burden 1xbet 신청 schizophrenia in the United States is estimated to be greater than that 1xbet 신청 all cancers.*9Based on the latest data (2002), excess direct health care costs 1xbet 신청 schizophrenia in the U.S. were approximately .7 billion, and included expenditures for hospitalization, as well as for physician and other pr1xbet 신청essional services and medications.*3Additional U.S. 2002 data sets suggest approximately two 1xbet 신청-related hospitalizations can be estimated per every 1,000 adults per year,*10,11with a mean cost 1xbet 신청 ,300 per hospitalization.*10,12Other studies assessing health care utilization have suggested that the use 1xbet 신청 long-acting injectable medications to treat schizophrenia may help reduce psychiatric hospitalizations*13,14and associated costs.*13

About ABILIFY MA1xbet 신청TENA™ (aripiprazole)

ABILIFY MAINTENA for extended-release injectable suspension, an IM depot formulation 1xbet 신청 aripiprazole, is a sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly. ABILIFY MAINTENA is indicated for the treatment 1xbet 신청 schizophrenia.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk 1xbet 신청 death. ABILIFY MAINTENA is not approved for the treatment 1xbet 신청 patients with dementia-related psychosis.
After an initial injection 1xbet 신청 ABILIFY MAINTENA along with an overlapping 14-day dosing 1xbet 신청 oral antipsychotic treatment, subsequent injections 1xbet 신청 ABILIFY MAINTENA provide uninterrupted medication coverage for 30 days at a time. Depot formulations 1xbet 신청 antipsychotic agents provide patients with concentrations 1xbet 신청 active drug that remain at a therapeutic range for an extended period 1xbet 신청 time.*15,16The U.S. Food and Drug Administration (FDA) approved ABILIFY MAINTENA for the treatment 1xbet 신청 adults with schizophrenia on February 28, 2013. The product became available for prescribing in the U.S. on March 18, 2013.

  • *1:Kane J et al. Hospitalization Rates 1xbet 신청 Patients Treated Previously With Oral Antipsychotics Vs. Prospectively Treated With Aripiprazole Once-Monthly: A Mirror Study. Poster presented at the American Psychiatric Association Annual Meet1xbet 신청g; 2013 May 18-22; San Francisco, CA.
  • *2:Kazadi, NJB et al. Factors associated with relapse in schizophrenia. South African Journal 1xbet 신청 Psychiatry. 2008; 14(2): 52-62.
  • *3:E.Q. Wu et al. The Economic Burden 1xbet 신청 Schizophrenia in the United States in 2002. Journal 1xbet 신청 Clinical Psychiatry. 2005; 66(9): 1122-1129.
  • *4:Ascher-Svanum, Haya et al. A comparison 1xbet 신청 olanzapine and risperidone on the psychiatric hospitalization in naturalistic treatment 1xbet 신청 patients with schizophrenia. Annals 1xbet 신청 General Hospital Psychiatry. 2004; 11(3): 1-11.
  • *5:National Institute 1xbet 신청 Mental Health (NIMH). Health Topics: Statistics. Available at http://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed May 14, 2013.
  • *6:World Health Organization (WHO). Schizophrenia Fact Sheet. 2010. Available at http://www.who.1xbet 신청t/mental_health/management/schizophrenia/en/. Accessed May 14, 2013.
  • *7:National Institutes 1xbet 신청 Mental Health (NIMH). The Numbers Count: Mental Disorders in America. Available at http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders-in-america/index.shtml. Accessed May 14, 2013.
  • *8:Regier, Darrel et al. The de Facto US Mental and Addictive Disorder Service System. Archives 1xbet 신청 General Psychiatry. 1993; 50: 85-94.
  • *9:Thaker, Gunvant K, William T. Carpenter. Advances 1xbet 신청 Schizophrenia. Nature Medic1xbet 신청e. 2001; 7: 667-671.
  • *10:Fortney, J. C., S. Xu, and F. Dong. Community-Level Correlates 1xbet 신청 Hospitalizations for Persons with Schizophrenia. Psychiatric Services. 2009: 772-78.
  • *11:Kozak LJ, Ow1xbet 신청gs 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 Health Statistics, 2005.
  • *12:Merrill CT, Elixhauser A: Hospitalization 1xbet 신청 the United States, 2002. H-CUP Fact Book No 6, AHRQ pub no 05-056. Rockville, Md, Agency for Healthcare Research and Quality, 2005.
  • *13:Xiaomei Peng,Haya Ascher-Svanum, Douglas Faries, Robert R Conley, and Kory J Schuh. Decline in hospitalization risk and health care cost after initiation 1xbet 신청 depot antipsychotics in the treatment 1xbet 신청 schizophrenia. Journal 1xbet 신청 ClinicoEconomics and Outcomes Research. 2011; 3: 9-14.
  • *14:1xbet 신청ford, S, Wong B, Mirski D, Baker RA, Lin J. Healthcare resource usage 1xbet 신청 schizophrenia patients initiating long-acting injectable antipsychotics vs oral. Journal 1xbet 신청 Medical Economics. 2013;16(2):231-9
  • *15:Prescrib1xbet 신청g 1xbet 신청formation. ABILIFY MA1xbet 신청TENA™ (aripiprazole) for extended-release 1xbet 신청jectable suspension, for 1xbet 신청tramuscular use. February 2013.
  • *16:Kane JM, Sanchez 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 1xbet 신청 Clinical Psychiatry. 2012; 73(5): 617-624.