Otsuka Pharmaceutical Co., Ltd. announced today that the European Medicines Agency (EMA) has approved a label extension for aripiprazole for the treatment 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 for the 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 the 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 the Y-MRS total score.

The 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 the recommended daily dose of 10 mg.

The treatment duration should be the minimum necessary for symptom control and must not exceed 12 weeks. The 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. Therefore, 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 for the treatment of multiple neurological disorders. While the 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 the United States, the 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 the 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.