Bristol-Myers Squibb And Otsuka Pharmaceutical Co., Ltd., Submit New Drug Application For Aripiprazole

08-Nov-2001

Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Company, Ltd. today announced that a New Drug Application (NDA) has been submitted to the U.S. food and Drug Administration (FDA) for aripiprazole, an investigational novel drug for the treatment of schizophrenia. If approved, aripiprazole will become the first member of the next generation of atypical antipsychotics.

The filing is based on an extensive global clinical development program for aripiprazole, involving numerous controlled trials of up to 52 weeks in duration involving more than 3,000 patients with schizophrenia. In these studies, aripiprazole provided statistically significant improvement of the symptoms of schizophrenia when compared to placebo. In addition, discontinuations due to side effects in patients treated with aripiprazole were not statistically different from discontinuations due to side effects in patients receiving placebo. Based on these data, Bristol-Myers Squibb and Otsuka Pharmaceutical also expect to file applications with additional regulatory authorities to market aripiprazole in countries around the world, including a filing with the European Medicines Evaluation Agency (EMEA) anticipated later this year. Aripiprazole is also being studied for possible utility in other psychiatric disorders, including psychosis in Alzheimer's disease and bipolar disease.

"There is a significant unmet medical need for patients suffering from schizophrenia. While currently available antipsychotic drugs help many patients, there is a substantial number of patients who exhibit either partial or inadequate response to therapy or who discontinue their treatment prematurely," said Jeffrey Lieberman, MD, Vice Chairman of Psychiatry, Professor of Psychiatry and Pharmacology, University of North Carolina at Chapel Hill. "One of the main reasons patients discontinue medication is because they feel the side effects are too disabling; therefore, reducing these side effects is crucial to establishing a successful treatment regimen."

Aripiprazole is believed to have a mechanism of action that is fundamentally different from available antipsychotics. Aripiprazole exhibits potent partial agonism of D2 dopamine receptors, associated with partial agonism of 5HT1a serotonin receptors and antagonism of 5HT2 serotonin receptors. Experts believe that regulating the dopamine and serotonin systems is critical to managing the symptoms of schizophrenia and it is hypothesized that the clinical effects of aripiprazole are mediated through its effects on these systems.

https://www.chemeurope.com/en/news/5791/bristol-myers-squibb-and-otsuka-pharmaceutical-co-ltd-submit-new-drug-application-for-aripiprazole.html