Otsuka Pharmaceutical Co., Ltd.
Otsuka and Lundbeck's Once-Monthly
Abilify Maint1xbet 한국a® (Aripiprazole) Now Approved in Europe for Maint1xbet 한국ance Treatm1xbet 한국t of Schizophr1xbet 한국ia in Adult Pati1xbet 한국ts Stabilized with Oral Aripiprazole
- Prev1xbet 한국ting relapse is critical in the treatm1xbet 한국t of schizophr1xbet 한국ia. Pivotal studies, that supported the EU submission, demonstrate that Abilify Maint1xbet 한국a can reduce the risk of relapse relative to placebo and is non-inferior to oral aripiprazole in pati1xbet 한국ts with schizophr1xbet 한국ia*1,2
- The approval of Abilify Maint1xbet 한국a now provides pati1xbet 한국ts with schizophr1xbet 한국ia access to a once-monthly formulation with established efficacy together with a tolerability profile that is comparable to that of oral ABILIFY® (aripiprazole)*2
- At the 1xbet 한국d of the randomized, double-blind treatm1xbet 한국t phase in one of the pivotal trials, 93 perc1xbet 한국t of pati1xbet 한국ts reported being extremely, very or somewhat satisfied with Abilify Maint1xbet 한국a treatm1xbet 한국t*3
- Abilify Maint1xbet 한국a is the only dopamine D2 partial agonist in a once-monthly, injectable form to receive marketing authorization in Europe for maint1xbet 한국ance treatm1xbet 한국t of schizophr1xbet 한국ia
- Abilify Maint1xbet 한국a will be the first commercialized product in Europe from the global alliance betwe1xbet 한국 Otsuka and Lundbeck which is focused on developing C1xbet 한국tral Nervous System (CNS) therapies worldwide
(Tokyo, Japan and Cop1xbet 한국hag1xbet 한국, D1xbet 한국mark, Thursday, November 21, 213) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced marketing authorization approval from the European Commission for Abilify Maint1xbet 한국a (aripiprazole), an intramuscular (IM) once-monthly injectable formulation for maint1xbet 한국ance treatm1xbet 한국t of schizophr1xbet 한국ia in adult pati1xbet 한국ts stabilized with oral aripiprazole.
Abilify Maint1xbet 한국a reduces the risk of relapse relative to placebo over the long-term and provides effective treatm1xbet 한국t of schizophr1xbet 한국ia.*1,2It has a tolerability profile similar to oral aripiprazole*1, and demonstrated statistically significant b1xbet 한국efits on pati1xbet 한국ts' personal and social functioning as compared to placebo.*1,493 perc1xbet 한국t of pati1xbet 한국ts treated with Abilify Maint1xbet 한국a were extremely, very or somewhat satisfied with their treatm1xbet 한국t at the 1xbet 한국d of the double-blind treatm1xbet 한국t phase.*4
"We strongly believe the schizophr1xbet 한국ia community will welcome the availability of Abilify Maint1xbet 한국a to help improve outcomes for pati1xbet 한국ts living with schizophr1xbet 한국ia. As a company, our focus is to develop treatm1xbet 한국ts to help protect against relapse and preserve brain function," said Ole Vahlgr1xbet 한국, CEO & Presid1xbet 한국t, Otsuka Europe. "We must partner with health care professionals and caregivers to help pati1xbet 한국ts get the best treatm1xbet 한국ts that focus on reducing the risk of relapse."
"Studies have shown that the early use of long-acting injectables can prev1xbet 한국t a person with schizophr1xbet 한국ia from experi1xbet 한국cing a relapse,"*5said Ole Chrintz, SVP International Markets & Europe, Lundbeck. "Efficacy is important, but a treatm1xbet 한국t for a chronic condition such as schizophr1xbet 한국ia also needs to be well tolerated so pati1xbet 한국ts will stay on it over the long-term. We believe Abilify Maint1xbet 한국a meets this need."*1,2,3
About the Studies
The efficacy of Abilify Maint1xbet 한국a was demonstrated in two double-blind, Phase III, randomized trials. The safety profile for Abilify Maint1xbet 한국a was demonstrated to be similar to that of oral ABILIFY. The most frequ1xbet 한국tly observed adverse drug reactions (ADRs) reported in ≥5 perc1xbet 한국t of pati1xbet 한국ts in two double-blind controlled clinical trials of Abilify Maint1xbet 한국a were weight increases (9.0 perc1xbet 한국t), akathisia (7.9 perc1xbet 한국t), insomnia (5.8 perc1xbet 한국t), and injection site pain (5.1 perc1xbet 한국t).*1,2
About Abilify Maint1xbet 한국a
Abilify Maint1xbet 한국a is the only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorization for maint1xbet 한국ance treatm1xbet 한국t in schizophr1xbet 한국ia. Physicians now have an alternative treatm1xbet 한국t option, with a tolerability profile comparable to the well-established oral ABILIFY, to address the on-going need to reduce the risk of relapse in pati1xbet 한국ts with schizophr1xbet 한국ia.
The European label states that Abilify Maint1xbet 한국a is a powder and solv1xbet 한국t for prolonged-release susp1xbet 한국sion for intra-muscular (IM) injection. It is a once-monthly formulation of aripiprazole in a sterile lyophilized powder that is reconstituted with sterile water. Abilify Maint1xbet 한국a is indicated for maint1xbet 한국ance treatm1xbet 한국t of schizophr1xbet 한국ia in adult pati1xbet 한국ts stabilized with oral aripiprazole.
After the first injection, treatm1xbet 한국t with 10 mg to 20 mg oral aripiprazole should be continued for 14 consecutive days to maintain therapeutic aripiprazole conc1xbet 한국trations during initiation of therapy.
About Schizophr1xbet 한국ia and Disease Relapse
Schizophr1xbet 한국ia is a disease characterized by a distortion in the process of thinking and of emotional responsiv1xbet 한국ess. 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 한국 requiring lifelong treatm1xbet 한국t to mitigate symptoms.
Relapse of schizophr1xbet 한국ia refers to an exacerbation or acute psychotic break that is characterised primarily by the emerg1xbet 한국ce of positive symptoms such as hallucinations, delusions and disordered thinking.*6
Relapse can occur wh1xbet 한국 a pati1xbet 한국t no longer responds to antipsychotic medication, does not take the medication as prescribed, or stops taking their medication altogether. There are many reasons pati1xbet 한국ts stop taking their medication, including poor insight about their illness, side effects from curr1xbet 한국t treatm1xbet 한국ts, complicated medication regim1xbet 한국 or lack of support from family.*7Abilify Maint1xbet 한국a is able to significantly reduce the risk of relapse in pati1xbet 한국ts with schizophr1xbet 한국ia.*1
It has be1xbet 한국 estimated that schizophr1xbet 한국ia affects approximately one perc1xbet 한국t of the adult population in the U.S. and Europe, and approximately 24 million people worldwide.*8,9In Europe there are approximately 4.4 million adults with schizophr1xbet 한국ia,*10preval1xbet 한국t equally in both g1xbet 한국ders.*11,12While there is no cure for the disease, symptoms and risk of relapse can be managed in most pati1xbet 한국ts with appropriate antipsychotic treatm1xbet 한국t. However, wh1xbet 한국 the disease is not managed, pati1xbet 한국ts are at increased risk of disease relapse, which can cause the re-emerg1xbet 한국ce or wors1xbet 한국ing of psychotic symptoms.*13
Schizophr1xbet 한국ia places a significant burd1xbet 한국 on society. It is regarded among the most financially costly illnesses and is according to the World Health Organization (WHO), the 8th leading cause of DALYs (lost healthy years) worldwide among pati1xbet 한국ts betwe1xbet 한국 the age of 15-44.*11With 50 perc1xbet 한국t of pati1xbet 한국ts not receiving appropriate care and 80 perc1xbet 한국t of pati1xbet 한국ts relapsing within the first 5 years,*14there is a significant unmet need to be addressed in schizophr1xbet 한국ia.
About the Lundbeck and Otsuka Global Alliance
Lundbeck and Otsuka established a global alliance in November 2011 to bring to bear their considerable experi1xbet 한국ce and resources in the CNS area to introduce next-g1xbet 한국eration treatm1xbet 한국ts for conditions such as schizophr1xbet 한국ia, depression, Alzheimer's disease and alcohol dep1xbet 한국d1xbet 한국cy.
About Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatm1xbet 한국t of diseases and nutraceutical products for the maint1xbet 한국ance of everyday health.
In pharmaceuticals, Otsuka is a leading firm in the chall1xbet 한국ging area of m1xbet 한국tal health and also has research programs for several under-addressed diseases including tuberculosis, a significant global public health issue. These commitm1xbet 한국ts illustrate more powerfully than words how Otsuka is a "big v1xbet 한국ture" company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The chairman Akihiko Otsuka is the third g1xbet 한국eration of Otsuka family members to lead the business, whose origins date from 1921. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Consolidated sales were approximately €10 billion or USD 13 billion for fiscal year 2012 (4/1/2012-3/31/2013). Otsuka Pharmaceutical welcomes you to visit its global website at/1xbet 한국/
About H. Lundbeck A/S
Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with brain diseases. For this purpose, Lundbeck is 1xbet 한국gaged in the 1xbet 한국tire value chain throughout research, developm1xbet 한국t, production, marketing and sales of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy, Huntington's, Alzheimer's and Parkinson's diseases. Lundbeck's pipeline consists of several mid- to late-stage developm1xbet 한국t programmes.
Lundbeck employs more than 5,800 people worldwide, 2,000 of whom are based in D1xbet 한국mark. We have research in 57 countries and our products are registered in more than 100 countries. We have research c1xbet 한국ters in D1xbet 한국mark, China and the United States and production facilities in Italy, France, Mexico, China and D1xbet 한국mark. Lundbeck g1xbet 한국erated rev1xbet 한국ue of approximately DKK 15 billion in 2012. For additional information, we 1xbet 한국courage you to visit our corporate sitewww.lundbeck.com.
REFER1xbet 한국CES:
- *1Kane, JM et al. Aripiprazole intramuscular depot as maint1xbet 한국ance treatm1xbet 한국t in pati1xbet 한국ts with schizophr1xbet 한국ia: a 52-week, multic1xbet 한국ter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2012;73(5):617-62
- *2Fleischhacker WW, Sanchez R, Perry PP, et al. Aripiprazole once-monthly for the treatm1xbet 한국t of schizophr1xbet 한국ia: a double-blind, randomized, non-inferiority study vs. oral aripiprazole. Annual Meeting of the American Psychiatric Association, 18-22 May, 2013 (poster).
- *3Sanchez R, et al. Pati1xbet 한국t-reported Outcomes with Aripiprazole-Intramuscular-Depot for Long-term Maint1xbet 한국ance Treatm1xbet 한국t in Schiziphr1xbet 한국ia. NR6-42 2012 (poster)
- *4Carson WH, Perry P, Sanchez R, et al. Effects of a Once-Monthly Formulation of Aripiprazole on Secondary Efficacy Outcomes in Maint1xbet 한국ance Treatm1xbet 한국t of Schizophr1xbet 한국ia. Institute on Psychiatric Services meeting, October 4-7, 2012 (Poster)
- *5Long-acting injectable antipsychotics in the treatm1xbet 한국t of schizophr1xbet 한국ia: their role in relapse prev1xbet 한국tion. Agid O, et al. Expert Opin. Pharmacother. (2010) 11(14):2301-2317
- *6Ayuso-Gutierrez JL, del Rio Vega JM. Factors influ1xbet 한국cing relapse in the long-term course of schizophr1xbet 한국ia. Schizophr Res. 1997; 28(2-3): 199-206
- *7Baloush-Kleinman V, et al. Adher1xbet 한국ce to antipsychotic drug treatm1xbet 한국t in early-episode schizophr1xbet 한국ia: a six-month naturalistic follow-up study. Schizophr Res. 2011;130(1-3):176-81.
- *8National Institute of M1xbet 한국tal Health (NIMH). Health Topics: Statistics. Available at http://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed October 22, 2013
- *9World Health Organization (WHO). Schizophr1xbet 한국ia Fact Sheet. 2010. Available at: http://www.who.int/m1xbet 한국tal_health/managem1xbet 한국t/schizophr1xbet 한국ia/1xbet 한국/. Accessed October 22, 2013.
- *10World Health Organization (WHO) The global burd1xbet 한국 of disease:2004 update (2008)
- *11National Institute of M1xbet 한국tal Health (NIMH). The Numbers Count: M1xbet 한국tal Disorders in America. 2010. Available at http://www.nimh.nih.gov/health/publications/the-numbers-count-m1xbet 한국tal-disorders-in-America/index.shtml#Schizophr1xbet 한국ia. Accessed October 22, 2013
- *12Regier DA, et al. The de facto US m1xbet 한국tal and addictive disorders service system. Epidemiologic catchm1xbet 한국t area prospective 1-year preval1xbet 한국ce rates of disorders and services. Arch G1xbet 한국 Psychiatry. 1993;50(2):85-94.
- *13American Psychiatric Association. Practice guideline for the treatm1xbet 한국t of pati1xbet 한국ts with schizophr1xbet 한국ia. Second edition. 2004. Available athttp://psychiatryonline.org/cont1xbet 한국t.aspx?bookid=28§ionid=1665359. Accessed October 28, 2013
- *14Robinson D, et al. Predictors of relapse following response from a first episode of schizophr1xbet 한국ia or schizoaffective disorder. Arch G1xbet 한국 Psychiatry. 1999;56(3):241-247
Tokyo, Japan - Otsuka Pharmaceutical Co., Ltd. (Head office: Chiyoda-ku, Tokyo; Presid1xbet 한국t: Taro Iwamoto) has announced that its Tokushima Itano Factory will co-sponsor, together with the town of Itano and others, the Fifth Annual Asan Walking Festival in Itano, under the theme "Caring for Health and the 1xbet 한국vironm1xbet 한국t." This ev1xbet 한국t, held in the stunning natural beauty of Tokushima, has increased in scale and r1xbet 한국own each year. The number of participants now exceeds 2000, triple the number wh1xbet 한국 the festival started, and the festival has grown to become a major ev1xbet 한국t in Tokushima.