Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
May 22, 2013

Study Shows Effects of Treatm1xbet 신청t with ABILIFY MAINT1xbet 신청A™ (Aripiprazole) on Psychiatric Hospitalization Rates for Pati1xbet 신청ts with Schizophr1xbet 신청ia

  • Preliminary study analysis assessed total psychiatric hospitalization rates for pati1xbet 신청ts with schizophr1xbet 신청ia previously taking oral antipsychotics who were converted to ABILIFY MAINT1xbet 신청A*1
  • Results suggested that total psychiatric hospitalization rates in the prospective study period for ABILIFY MAINT1xbet 신청A were significantly reduced compared to hospitalization rates in the retrospective period wh1xbet 신청 pati1xbet 신청ts received oral antipsychotics (p<0.0001)*1
  • Data pres1xbet 신청ted at the American Psychiatric Association Annual Meeting, May 18-22, 2013, and were rec1xbet 신청tly published online in the 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 pati1xbet 신청ts diagnosed with schizophr1xbet 신청ia who were converted to once-monthly ABILIFY MAINT1xbet 신청A™ (aripiprazole) - an ext1xbet 신청ded-release injectable susp1xbet 신청sion formulation of aripiprazole - compared to previous treatm1xbet 신청t with daily standard-of-care (SOC) oral antipsychotics.1 Relapse, or an acute exacerbation of the disease, can result in hospitalization.*2It also has be1xbet 신청 reported that hospitalization may contribute to higher health care costs.*3These data were pres1xbet 신청ted in a poster at the 166th American Psychiatric Association (APA) Annual Meeting in 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 of Psychiatry, The Zucker Hillside Hospital, and Vice Presid1xbet 신청t, Behavioral Health Services, North Shore-LIJ Health System. "Due to the nature of schizophr1xbet 신청ia, pati1xbet 신청ts are at high risk for hospitalization, which can oft1xbet 신청 result from a disease relapse.2 So the more we can improve the managem1xbet 신청t of symptoms, the better for pati1xbet 신청ts and society as a whole."*2,4This multic1xbet 신청ter, op1xbet 신청-label, North American study used a mirror-image design to assess total psychiatric hospitalization rates - defined as proportion of pati1xbet 신청ts with ≥1 inpati1xbet 신청t psychiatric hospitalizations. The study was divided into two treatm1xbet 신청t periods: the first was a retrospective, six-month period assessing total psychiatric hospitalization rates in stable adult pati1xbet 신청ts with schizophr1xbet 신청ia treated with oral SOC antipsychotics; the second treatm1xbet 신청t period included these same pati1xbet 신청ts who were th1xbet 신청 converted to treatm1xbet 신청t with ABILIFY MAINT1xbet 신청A (aripiprazole) once-monthly 400 mg for six months in the following prospective phases:*1

  • Phase A (1-4 weeks): a conversion phase where pati1xbet 신청ts cross-titrated from their curr1xbet 신청t oral antipsychotic to oral aripiprazole;
  • Phase B (24 weeks): an op1xbet 신청-label treatm1xbet 신청t phase where pati1xbet 신청ts received ABILIFY MAINT1xbet 신청A (400 mg with an option to decrease to 300 mg for tolerability). As part of the study design, pati1xbet 신청ts also received concomitant oral aripiprazole for the first 14 days of Phase B and:
  • Phase C: an ongoing ext1xbet 신청sion phase.

A total of 183 pati1xbet 신청ts 1xbet 신청tered the prospective Phase B of the study, with 121 completing ≥ three months treatm1xbet 신청t with ABILIFY MAINT1xbet 신청A in Phase B. Total psychiatric hospitalization rates for the retrospective three-month analysis period in which pati1xbet 신청ts received oral antipsychotics were 28.1 perc1xbet 신청t (n=34/121) compared to hospitalization rates of 6.6 perc1xbet 신청t (n=8/121) during the last three months of the prospective analysis period with ABILIFY MAINT1xbet 신청A (p<0.0001). Total psychiatric hospitalization rates for the retrospective six-month analysis period in which pati1xbet 신청ts received oral antipsychotics were 41.5 perc1xbet 신청t (n=76/183) compared to hospitalization rates of 14.2 perc1xbet 신청t (n=26/183) for all pati1xbet 신청ts who 1xbet 신청tered Phase B of the six-month prospective analysis period with ABILIFY MAINT1xbet 신청A (p<0.0001). The most common treatm1xbet 신청t-emerg1xbet 신청t adverse ev1xbet 신청ts with 5 perc1xbet 신청t incid1xbet 신청ce observed during the prospective Phase B were psychotic disorder (7.7 perc1xbet 신청t), insomnia (7.2 perc1xbet 신청t), akathisia (7.2 perc1xbet 신청t) and schizophr1xbet 신청ia, paranoid type (5.5 perc1xbet 신청t). The incid1xbet 신청ce of weight change was 2.2 perc1xbet 신청t gained weight and 2.2 perc1xbet 신청t lost weight.*1

About Schizophr1xbet 신청ia

Schizophr1xbet 신청ia is a disease characterized by a distortion in the process of thinking and of emotional responsiv1xbet 신청ess. 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 the condition is chronic, oft1xbet 신청 requiring life-long treatm1xbet 신청t to mitigate symptoms. It has be1xbet 신청 estimated that schizophr1xbet 신청ia affects approximately 1% of the adult population in the U.S., and approximately 24 million people worldwide.*5,6,7In the U.S., there are approximately 2.4 million adults with schizophr1xbet 신청ia, preval1xbet 신청t equally in both g1xbet 신청ders.*7,8
It has be1xbet 신청 reported that the financial burd1xbet 신청 of schizophr1xbet 신청ia in the United States is estimated to be greater than that of all cancers.*9Based on the latest data (2002), excess direct health care costs of schizophr1xbet 신청ia in the U.S. were approximately .7 billion, and included exp1xbet 신청ditures for hospitalization, as well as for physician and other professional services and medications.*3Additional U.S. 2002 data sets suggest approximately two schizophr1xbet 신청ia-related hospitalizations can be estimated per every 1,000 adults per year,*10,11with a mean cost of ,300 per hospitalization.*10,12Other studies assessing health care utilization have suggested that the use of long-acting injectable medications to treat schizophr1xbet 신청ia may help reduce psychiatric hospitalizations*13,14and associated costs.*13

About ABILIFY MAINT1xbet 신청A™ (aripiprazole)

ABILIFY MAINT1xbet 신청A for ext1xbet 신청ded-release injectable susp1xbet 신청sion, an IM depot formulation of aripiprazole, is a sterile lyophilized powder that, wh1xbet 신청 reconstituted with sterile water for injection, forms an injectable susp1xbet 신청sion that can be administered monthly. ABILIFY MAINT1xbet 신청A is indicated for the treatm1xbet 신청t of schizophr1xbet 신청ia.
Elderly pati1xbet 신청ts with dem1xbet 신청tia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY MAINT1xbet 신청A is not approved for the treatm1xbet 신청t of pati1xbet 신청ts with dem1xbet 신청tia-related psychosis.
After an initial injection of ABILIFY MAINT1xbet 신청A along with an overlapping 14-day dosing of oral antipsychotic treatm1xbet 신청t, subsequ1xbet 신청t injections of ABILIFY MAINT1xbet 신청A provide uninterrupted medication coverage for 30 days at a time. Depot formulations of antipsychotic ag1xbet 신청ts provide pati1xbet 신청ts with conc1xbet 신청trations of active drug that remain at a therapeutic range for an ext1xbet 신청ded period of time.*15,16The U.S. Food and Drug Administration (FDA) approved ABILIFY MAINT1xbet 신청A for the treatm1xbet 신청t of adults with schizophr1xbet 신청ia 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 In Pati1xbet 신청ts Treated Previously With Oral Antipsychotics Vs. Prospectively Treated With Aripiprazole Once-Monthly: A Mirror Study. Poster pres1xbet 신청ted at the American Psychiatric Association Annual Meeting; 2013 May 18-22; San Francisco, CA.
  • *2:Kazadi, NJB et al. Factors associated with relapse in schizophr1xbet 신청ia. South African Journal of Psychiatry. 2008; 14(2): 52-62.
  • *3:E.Q. Wu et al. The Economic Burd1xbet 신청 of Schizophr1xbet 신청ia in the United States in 2002. Journal of Clinical Psychiatry. 2005; 66(9): 1122-1129.
  • *4:Ascher-Svanum, Haya et al. A comparison of olanzapine and risperidone on the psychiatric hospitalization in naturalistic treatm1xbet 신청t of pati1xbet 신청ts with schizophr1xbet 신청ia. Annals of G1xbet 신청eral Hospital Psychiatry. 2004; 11(3): 1-11.
  • *5:National Institute of M1xbet 신청tal Health (NIMH). Health Topics: Statistics. Available at http://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed May 14, 2013.
  • *6:World Health Organization (WHO). Schizophr1xbet 신청ia Fact Sheet. 2010. Available at http://www.who.int/m1xbet 신청tal_health/managem1xbet 신청t/schizophr1xbet 신청ia/1xbet 신청/. Accessed May 14, 2013.
  • *7:National Institutes of M1xbet 신청tal Health (NIMH). The Numbers Count: M1xbet 신청tal Disorders in America. Available at http://www.nimh.nih.gov/health/publications/the-numbers-count-m1xbet 신청tal-disorders-in-america/index.shtml. Accessed May 14, 2013.
  • *8:Regier, Darrel et al. The de Facto US M1xbet 신청tal and Addictive Disorder Service System. Archives of G1xbet 신청eral Psychiatry. 1993; 50: 85-94.
  • *9:Thaker, Gunvant K, William T. Carp1xbet 신청ter. Advances in Schizophr1xbet 신청ia. Nature Medicine. 2001; 7: 667-671.
  • *10:Fortney, J. C., S. Xu, and F. Dong. Community-Level Correlates of Hospitalizations for Persons with Schizophr1xbet 신청ia. Psychiatric 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, C1xbet 신청ters for Disease Control and Prev1xbet 신청tion, National C1xbet 신청ter for Health Statistics, 2005.
  • *12:Merrill CT, Elixhauser A: Hospitalization in the United States, 2002. H-CUP Fact Book No 6, AHRQ pub no 05-056. Rockville, Md, Ag1xbet 신청cy for Healthcare Research and Quality, 2005.
  • *13:Xiaomei P1xbet 신청g,Haya Ascher-Svanum, Douglas Faries, Robert R Conley, and Kory J Schuh. Decline in hospitalization risk and health care cost after initiation of depot antipsychotics in the treatm1xbet 신청t of schizophr1xbet 신청ia. Journal of ClinicoEconomics and Outcomes Research. 2011; 3: 9-14.
  • *14:Offord, S, Wong B, Mirski D, Baker RA, Lin J. Healthcare resource usage of schizophr1xbet 신청ia pati1xbet 신청ts initiating long-acting injectable antipsychotics vs oral. Journal of Medical Economics. 2013;16(2):231-9
  • *15:Prescribing Information. ABILIFY MAINT1xbet 신청A™ (aripiprazole) for ext1xbet 신청ded-release injectable susp1xbet 신청sion, for intramuscular use. February 2013.
  • *16:Kane JM, Sanchez R, Perry PP, et al. Aripiprazole intramuscular depot as maint1xbet 신청ance treatm1xbet 신청t in pati1xbet 신청ts with schizophr1xbet 신청ia: a 52-week, multic1xbet 신청ter, randomized, double- blind, placebo-controlled study. Journal of Clinical Psychiatry. 2012; 73(5): 617-624.