Approval of Abilify (aripiprazole) for the treatment of acute bipolar mania

Oct 4 2004

Bristol-Myers Squibb and Otsuka Pharmaceutical have announced that the U.S. Food and Drug Administration (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.i The most common side effects reported in clinical trials (>5 percent incidence and occurred at least twice as frequently in the Abilify-treated group compared to the placebo or sugar pill group) were akathisia (an inner sense of restlessness and need to move about), constipation and accidental injury.ii The rate of discontinuation due to side effect was low (aripiprazole-treated 11 percent and placebo-treated 9 percent). In these clinical trials with Abilify, there was no significant difference from placebo with respect to weight gain, blood sugar levels, or lipids. The proportion of patients meeting a weight gain criterion of >7 percent of body weight was 3 percent for Abilify compared to 2 percent for placebo.iii

"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, M.D., 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." In short-term, placebo-controlled trials of bipolar mania, somnolence was reported in 14 percent of patients on Abilify (aripiprazole) compared to 7 percent of patients on placebo.iv

"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. "This approval underscores our commitment to delivering innovative solutions that address unmet needs for a broad spectrum of patients with mental illness, as well as their families and health care providers."

"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 agonistv,vi, Abilify represents an important option in the treatment of bipolar I disorder."

Bipolar I disorder affects more than 2 million Americans, and onset generally occurs before the age of 30. 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. During the depressive phase, the patient may feel so hopeless that they are incapable of seeking or accepting help, and they may believe that they cannot be helped. Mixed episodes involve the simultaneous occurrence of depressive and manic symptoms. People with bipolar I disorder may also experience some psychotic symptoms, including hallucinations and paranoia. The duration of mood episodes range from hours or days to many months. 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.