Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Psychiatry/Psychology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Bristol-Myers Squibb, Otsuka America Pharmaceutical
Approval Status: Approved November 2002
Treatment Area: Schizophrenia
Abilify (aripiprazole) is an orally administered drug approved
in November 2002 for the treatment of schizophrenia. It is a
dopamine partial agonist and a seratonin antagonist.
Abilify oral tablets are available in 10mg, 15mg, 20mg, and 30mg
doses. The 15mg strength is the recommended starting and effective
Four short-term, placebo-controlled clinical trials were
conducted with Abilify in acute replapsed inpatients with
schizophrenia. In three of the four trials, efficacy was measured
by the Positive and Negative Syndrome Scale (PANSS) and the
Clinical Global Impression Severity of Illness Score (CGI-S). In
the three trials, Abilify was statistically superior to placebo
using these measures.
In the fourth trial, efficacy was measured by a responder
analysis based on the CGI-S and the change in Brief Psychiatric
Rating Scale (BPRS). Abilify was statistically superior to placebo
based on the CGI-S, but not in the BPRS measure.
Clinical efficacy was demonstrated by the 15mg, 20mg and 30mg
doses in two trials each. Clinical efficacy was shown for the 10mg
dose in one trial. No evidence of clinical superiority was shown by
the higher doses compared to the lowest dose.
The following are some of the adverse events that were
experienced in clinical trials by 2% or more of subjects receiving
- Somnolence (sleepiness)
- Akathisia (condition of motor restlessness)
No siginficant differences were found in incidence of
discontinuation due to adverse events experienced by the
aripiprazole group compared to the placebo group.
Note: Neuroleptic malignant syndrome (NMS), a rare but sometimes
fatal condition, has been associated with antipsychotic drugs,
including Abilify. In addition, tardive dyskinesia (TD) has also
been associated with antipsychotic drugs.
Mechanism of Action
Abilify is a dopamine partial agonist and a seratonin
For additional information about Abilify, please visit product
web site at www.abilify.com.