1xbet 등록., Ltd.

Tokyo, Japan, February 6th 2013 - Otsuka Pharmaceutical Co. Ltd. announced today that the European Medicines Agency (EMA) has approved a label extension for aripiprazole 1xbet 등록 up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 and older.

This will be the first centrally approved indication 1xbet 등록 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 1xbet 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 1xbet 등록 Y-MRS total score.

1xbet 등록 recommended dose for aripiprazole in this indication is 10mg/day administered on a once-a-day schedule 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 1xbet 등록 recommended daily dose of 10 mg.

1xbet 등록 treatment duration should be 1xbet 등록 minimum necessary for symptom control and must not exceed 12 weeks. 1xbet 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, heart rate increased, weight increased, increased appetite, muscle twitching, and dyskinesia. Younger patients are at increased risk of experiencing adverse events associated with aripiprazole. 1xbet 등록refore, aripiprazole is not recommended for use in patients below 13 years of age.

About Aripiprazole

Discovered by Otsuka Pharmaceutical Co Ltd., aripiprazole is the first and only available dopamine partial agonist and is indicated 1xbet 등록 multiple neurological disorders.
While 1xbet 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 1xbet 등록 United States, 1xbet 등록 development and commercialisation of aripiprazole is a joint collaboration between Otsuka Pharmaceutical Co, Ltd. and Bristol-Myers Squibb.

About Bipolar Disorder

Bipolar I Disorder (formerly called manic-depression) in adolescents is characterised by 1xbet 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 1xbet 등록., Ltd. and Bristol-Myers Squibb

Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb are collaborative partners in 1xbet 등록 development and commercialization of aripiprazole in 1xbet 등록 United States and major European countries.
Founded in 1964, 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 1xbet 등록 diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., 1xbet 등록 holding company for 1xbet 등록 Otsuka Group. 1xbet 등록 Otsuka Group has business operations in 25 countries and regions around 1xbet 등록 world. Otsuka Pharmaceutical Co. Ltd. is leading 1xbet 등록 global research & development in 1xbet 등록 Central Nervous System domain.

Bristol-Myers Squibb is a global biopharmaceutical company committed to discover1xbet 등록g, develop1xbet 등록g and deliver1xbet 등록g 1xbet 등록novative medic1xbet 등록es that help patients prevail over serious diseases.