Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) approved the supplemental New Drug Application for the atypical antipsychotic Abilify (aripiprazole) for the treatment of schizophrenia in adolescents aged 13-17 years.
In adolescents, Abilify treats positive and negative symptoms of schizophrenia. The FDA first approved Abilify for the treatment of schizophrenia in adults on November 15, 2002.
"Until now, FDA-approved treatment options for adolescent patients with schizophrenia were limited," said Robert Findling, M.D., Director of Child and Adolescent Psychiatry, University Hospitals Case Medical Centre, Cleveland, Ohio. "The approval of this new indication for Abilify provides an additional effective treatment option for these patients."
This approval is based on results from a six-week, randomised, double-blind, placebo-controlled study that demonstrated significant improvement with Abilify compared to placebo on the primary efficacy endpoint, Positive and Negative Syndrome Scale (PANSS) Total Score.
"We are extremely pleased that Abilify, the first available dopamine partial agonist, is approved for the treatment of paediatric patients (13 to 17 years of age) suffering from schizophrenia," said Tatsuo Higuchi, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "Abilify (aripiprazole) offers an effective new option to help treat this serious mental illness."
"Schizophrenia is one of the most complex of all mental health disorders," said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, Research and Development, Bristol-Myers Squibb. "We remain committed to providing innovative therapies, such as ABILIFY, to help patients, including adolescents, living with schizophrenia."
The findings are from a six-week, double blind, randomised, placebo-controlled, multi-centre study that evaluated the efficacy and safety of Abilify in paediatric patients, 13-17 years old, with a primary diagnosis of schizophrenia. The study, sponsored by Otsuka Pharmaceutical Co., Ltd. and its US subsidiary, Otsuka Pharmaceutical Development & Commercialisation, Inc. (Princeton, N.J.), was conducted at 101 centres in 13 countries and enrolled 302 ethnically diverse paediatric patients. All patients were experiencing an acute episode of schizophrenia and required hospitalisation at the time of enrolment. After a minimum three-day washout period without any antipsychotic treatment, paediatric patients were randomly assigned to receive one of two fixed doses of Abilify. Abilify was started at 2 mg/day and titrated to the target dose.
The primary efficacy endpoint was the mean change from baseline to endpoint (Week 6) in a standard measure called the PANSS Total Score, which can range from 30 (no symptoms) to 210 points (most severe symptoms). Safety evaluations included incidence of adverse events, discontinuation rate due to adverse events and laboratory measures.
Approximately 85 per cent of patients completed the six-week study (84 percent of Abilify 10 mg, 82 per cent of Abilify 30 mg and 90 per cent of placebo-treated patients). Both doses of Abilify demonstrated significant improvement when compared to placebo in mean change from baseline to endpoint (Week 6) in PANSS Total Score.
In this study of paediatric patients with schizophrenia, common adverse events (greater than or equal to 5 per cent and at least twice the rate of placebo) associated with Abilify were extrapyramidal disorder, somnolence and tremor. These common adverse reactions appeared to have a possible dose response relationship: extrapyramidal disorder (Abilify 10 mg: 13 per cent; Abilify 30 mg: 21.6 per cent; placebo: 5 per cent), somnolence [Abilify 10 mg: 11 per cent; Abilify (aripiprazole) 30 mg: 21.6 per cent; placebo: 6 per cent] and tremor (Abilify 10 mg: 2 per cent; Abilify 30 mg: 11.8 per cent; placebo: 2 per cent). The discontinuation rate due to an adverse event was 5 per cent for Abilify and 2 per cent for placebo.
In this six-week study, weight gain greater than or equal to 7 percent increase from baseline was seen in 5 per cent of paediatric patients treated with Abilify and 1 per cent of placebo-treated patients. The mean change from baseline in weight was 0.13 kilograms (kg) for Abilify and -0.83 kg for placebo.
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported at an increased incidence in clinical trials of elderly patients with dementia-related psychosis treated with Abilify
Neuroleptic malignant syndrome (NMS) - As with all antipsychotic medications, a rare and potentially fatal condition known as NMS has been reported with Abilify. NMS can cause hyperpyrexia, muscle rigidity, diaphoresis, tachycardia, irregular pulse or blood pressure, cardiac dysrhythmia, and altered mental status. If signs and symptoms appear, immediate discontinuation is recommended
Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb are collaborative partners in the development and commercialisation of Abilify (aripiprazole) in the United States and major European countries.
Abilify was discovered by Otsuka Pharmaceutical Co., Ltd. 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 for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka and its consolidated subsidiaries earned US$7.2 billion in annual revenues in fiscal 2006.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.