Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co, Ltd announced that the US FDA has approved Abilify (aripiprazole) for the treatment of acute bipolar mania, including manic and mixed episodes associated with bipolar disorder.
The FDA approval is based on positive results from two placebo-controlled, three-week trials of 516 hospitalized patients with bipolar I disorder who were experiencing an acute manic or mixed episode. In these studies, Abilify demonstrated significant improvement in the symptoms of acute manic or mixed episodes, the company release said.
"The approval of Abilify for the treatment of acute bipolar mania is important news for the millions of people in this country who suffer from bipolar I disorder," said Paul Keck, professor of psychiatry, pharmacology and neuroscience, and vice chairman for research, Department of Psychiatry, University of Cincinnati College of Medicine. "Abilify provides symptom improvement for acute mania, with a low incidence of somnolence," he added. In short-term, placebo-controlled trials of bipolar mania, somnolence was reported in 14 per cent of patients on Abilify (aripiprazole) compared to 7 per cent of patients on placebo.
"We are pleased that Abilify has reached another significant medical milestone. We are committed to educating patients and their doctors about Abilify and the important role it can play in improving mental health," said Peter R Dolan, chairman and chief executive officer, Bristol-Myers Squibb.
"We are very proud to have discovered Abilify, a unique pharmacological agent that represents our strong focus on pharmaceutical innovation," said Tatsuo Higuchi, president and representative director, Otsuka Pharmaceutical Co., Ltd. "As the first and only dopamine partial agonist, Abilify represents an important option in the treatment of bipolar I disorder."
Abilify was approved by the FDA in 2002 for the treatment of schizophrenia. The efficacy and tolerability of Abilify in schizophrenia was established by short-term and longer-term controlled trials. Abilify is indicated for the treatment of schizophrenia and acute manic and mixed episodes associated with bipolar disorder.
Bipolar I disorder can include manic, depressive, or mixed phases, or episodes. During the manic phase of the illness, the person's mood is elated and judgment impaired, and they are likely to deny that they are ill and need help. Bipolar I disorder can be difficult to recognize, and even after a diagnosis is made, it is often extremely challenging to convince a person with bipolar I disorder to seek and maintain treatment.