The U.S. Food and Drug Administration (FDA) approved Abilify (aripiprazole), a new antipsychotic medication indicated for the treatment of schizophrenia. Bristol-Myers Squibb Company and Otsuka America Pharmaceutical Inc will jointly market Abilify in the United States. The companies anticipate that Abilify tablets will be widely available in pharmacies within two weeks.
Clinical studies involving 1,238 patients with acute relapse of schizophrenia demonstrated that treatment with Abilify provided significant improvements in the positive and negative symptoms of schizophrenia.
Importantly, treatment with Abilify was associated with minimal weight change, minimal extrapyramidal symptoms (EPS is a group of involuntary muscle movement disorders) and a modest difference in sedation compared to placebo (11% vs. 8%). Additionally, the incidence of QTc interval prolongation with Abilify treatment is not different from placebo.
"Abilify represents an important new treatment for schizophrenia," said Jeffrey Lieberman, vice chairman of psychiatry, professor of psychiatry and pharmacology, University of North Carolina at Chapel Hill. "Clinical data show that patients treated with Abilify experience significant improvement of their symptoms, and the medication demonstrated an excellent safety and tolerability profile. Given that a large percentage of patients discontinue or switch antipsychotic medication due to inadequate response or side effects, the addition of Abilify to our armamentarium is very exciting."
Schizophrenia affects more than two million Americans, and about one percent of the population worldwide. Schizophrenia interferes with a person's ability to think clearly, manage emotions, make decisions and relate to others. This illness tends to manifest itself in early adulthood and is characterized by positive symptoms, such as hallucinations, delusions, and paranoia, as well as negative symptoms, such as social withdrawal and emotional flatness. While there is no cure for schizophrenia, it is a treatable illness.