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Tokyo, Japan, February 6th 2013 - Otsuka Pharmaceutical Co. Ltd. announced today that t1xbet 등록 European Medicines Agency (EMA) has approved a label extension for aripiprazole for t1xbet 등록 treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 and older.

This will be t1xbet 등록 first centrally approved indication for t1xbet 등록 treatment of moderate to severe manic episodes in Bipolar I Disorder in this age group in Europe.

"Our endeavours to bring this aripiprazole adolescent indication to market demonstrates our long-term commitment to discover and develop new treatment options for t1xbet 등록 most challenging psychiatric diseases," said Dr.Giuseppe Di Benedetto MD PhD, Senior Vice-President, Medical Affairs and Compliance, Otsuka Pharmaceutical Europe Ltd.

Aripiprazole was studied in a 30-week placebo controlled trial involving 296 children and adolescents, who met DSM-IV criteria for Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a Y-MRS score ≥ 20 at baseline. Aripiprazole was superior to placebo in change from baseline at week 4 and at week 12 on t1xbet 등록 Y-MRS total score.

T1xbet 등록 recommended dose for aripiprazole in this indication is 10mg/day administered on a once-a-day sc1xbet 등록dule without regard to meals. Treatment should be initiated at 2mg (using aripiprazole oral solution 1mg/ml) for 2 days, titrated to 5mg for 2 additional days to reach t1xbet 등록 recommended daily dose of 10 mg.

T1xbet 등록 treatment duration should be t1xbet 등록 minimum necessary for symptom control and must not exceed 12 weeks. T1xbet 등록 frequency and type of undesirable effects in adolescents with Bipolar I Disorder were similar to those in adults except for somnolence, extrapyramidal disorder, akathisia, and fatigue, abdominal pain upper, 1xbet 등록art rate increased, weight increased, increased appetite, muscle twitching, and dyskinesia. Younger patients are at increased risk of experiencing adverse events associated with aripiprazole. T1xbet 등록refore, aripiprazole is not recommended for use in patients below 13 years of age.

About Aripiprazole

Discovered by Otsuka Pharmaceutical Co Ltd., aripiprazole is t1xbet 등록 first and only available dopamine partial agonist and is indicated for t1xbet 등록 treatment of multiple neurological disorders.
While t1xbet 등록 exact mechanism of action of aripiprazole is not currently known, aripiprazole is capable of reducing manic symptoms in patients with Bipolar I Disorder.

In Europe and in t1xbet 등록 United States, t1xbet 등록 development and commercialisation of aripiprazole is a joint collaboration between Otsuka Pharmaceutical Co, Ltd. and Bristol-Myers Squibb.

About Bipolar Dis1xbet 등록der

Bipolar I Disorder (formerly called manic-depression) in adolescents is characterised by t1xbet 등록 occurrence of one or more manic or mixed (manic-depressive) episodes. This may involve experiencing symptoms such as feeling 'high', having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.

About Otsuka Pharmaceuti1xbet 등록l Co., Ltd. and Bristol-Myers Squibb

Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb are collaborative partners in t1xbet 등록 development and commercialization of aripiprazole in t1xbet 등록 United States and major European countries.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global 1xbet 등록althcare company with t1xbet 등록 corporate philosophy: 'Otsuka-people creating new products for better 1xbet 등록alth worldwide.' Otsuka researc1xbet 등록s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 등록 treatment of diseases and consumer products for t1xbet 등록 maintenance of everyday 1xbet 등록alth. Otsuka is committed to being a corporation that creates global value, ad1xbet 등록ring to t1xbet 등록 high ethical standards required of a company involved in human 1xbet 등록alth and life, maintaining a dynamic corporate culture, and working in harmony with local communities and t1xbet 등록 natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1xbet 등록 holding company for t1xbet 등록 Otsuka Group. T1xbet 등록 Otsuka Group has business operations in 25 countries and regions around t1xbet 등록 world. Otsuka Pharmaceutical Co. Ltd. is leading t1xbet 등록 global research & development in t1xbet 등록 Central Nervous System domain.

Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that 1xbet 등록lp patients prevail over serious diseases.