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 percent vs. 8 percent). 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.
"This approval will enable Bristol-Myers Squibb to further realize its mission of extending and enhancing human life in important new ways," said Peter R. Dolan, chairman and chief executive officer. "For patients and their caregivers, as well as for physicians, Abilify represents new hope for thousands of people with schizophrenia. For Bristol-Myers Squibb, it marks the beginning of a promising new era for our company when we will be providing a new generation of innovative medicines for the benefit of patients everywhere. And I am pleased that we have Otsuka at our side as we begin this great journey."
"We at Otsuka are very proud to have discovered Abilify and to have developed it jointly with Bristol-Myers Squibb into a product that represents an important option in the treatment of serious mental illness," said Tatsuo Higuchi, president, Otsuka Pharmaceutical Co. Ltd. "Abilify highlights Otsuka's strong passion and commitment to scientific discovery, and introducing this important new compound in the United States is a great accomplishment for us. Abilify will become a new and valuable treatment option to help many people who live with schizophrenia to lead more productive lives."