Skip to Content

FDA approves Abilify (aripiprazole) for treatment of acute bipolar mania, including manic and mixed episodes

PRINCETON, N.J. and TOKYO, JAPAN, October 1, 2004 -- Bristol-Myers Squibb and Otsuka Pharmaceutical announced that the 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 (greater than or equal to 5% 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% and placebo-treated 9%).

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 greater than or equal to 7% of body weight was 3% for Abilify compared to 2% 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% of patients on Abilify compared to 7% of patients on placebo.(iv)

Bipolar I disorder affects more than two 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.

About Abilify

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. Since its approval, over 2.4 million prescriptions have been written in the United States.(vii) Abilify is indicated for the treatment of schizophrenia and acute manic and mixed episodes associated with bipolar disorder.

Abilify is available by prescription only. Patients should talk to their healthcare provider for more information. To learn more about Abilify and for full product information, visit

Important Safety Information

A rare but potentially fatal complex of symptoms referred to as neuroleptic malignant syndrome (NMS) has been reported with antipsychotic medicines, including Abilify (aripiprazole). Another condition associated with these medicines is called tardive dyskinesia (TD), a condition that can cause potentially irreversible involuntary movements.

Increases in blood sugar levels (hyperglycemia) have been reported in patients treated with these medicines, including Abilify. Hyperglycemia, in some cases extreme and associated with coma or death, has been reported in patients treated with atypical antipsychotics. It is important that patients tell their healthcare provider if they are diabetic, have risk factors for diabetes (e.g., obesity, family history of diabetes), or if they are experiencing unexpected increases in thirst, urination, or hunger. Before starting treatment with atypical antipsychotics, patients should have their glucose tested and also be monitored during treatment.

Lightheadedness or faintness (orthostatic hypotension), caused by rising too quickly from a sitting or lying position, has been reported with these medicines. Abilify should be used cautiously if a patient has a history of seizures.

Patients should not drive or operate heavy machinery until they know how Abilify affects them.

Patients should talk to their healthcare provider if they are pregnant or intend to become pregnant. Patients should also discuss with their healthcare provider all prescription and non-prescription medicines they are taking or plan to take.

Other common side effects are: headache, agitation, anxiety, insomnia, nausea, upset stomach, sleepiness, an inner sense of restlessness and need to move about (akathisia), lightheadedness, vomiting, constipation, and tremors.


i  Abilify Product Labeling, p. 2
ii  Abilify Product Labeling, p. 4
iii Abilify Product Labeling, p. 5
iv  Abilify Product Labeling, p. 3
v  Burris KD, Molski TF, Xu C, et al. Aripiprazole, a novel antipsychotic, is a high-affinity partial agonist at human dopamine D2 receptors. J Pharmacol Exp Ther. 2002;302:381-389.
vi  Kikuchi T, Tottori K, Uwahodo Y, et al. 7-{4-[4-(2,3-dichlorophenyl)-piperazinyl]butyloxy}-3,4-dihydro-2 (1H)-quinolinone (OPC-14597), a new putative antipsychotic drug with both presynaptic dopamine autoreceptor agonistic activity and postsynaptic D2 receptor antagonistic activity. J Pharmacol Exp Ther. 1995;274:329-336.
vii IMS Weekly NPA Plus, Verispan longitudinal database as of August 20, 2004. 

Source: Bristol-Myers Squibb and Otsuka Pharmaceutical

Posted: October 2004