Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co. Ltd. announced that the U.S. Food and Drug Administration (U.S. FDA) approved a Supplemental New Drug Application (sNDA) for Abilify (aripiprazole) for maintaining stability in patients with schizophrenia.
"Because schizophrenia is a chronic illness that requires ongoing treatment, it is important for physicians, consumers and family members to have information regarding the longer-term use of medication," said Dr. Peter Weiden, Director of the Schizophrenia Research Program and Professor of Psychiatry, SUNY Downstate Medical Center. "These data demonstrate that Abilify is efficacious in the treatment of schizophrenia for up to 26 weeks. In addition, the study demonstrated there were no medically important differences between Abilify and placebo in several metabolic measures."
The sNDA included results from a placebo-controlled trial involving 310 inpatients or outpatients meeting DSM-IV criteria for schizophrenia who were, by history, symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from their antipsychotic medications and randomized to Abilify 15 mg/daily or placebo for up to 26 weeks of observation for relapse. In this study, patients who received Abilify 15mg/daily experienced a significantly longer time to relapse over the subsequent 26 weeks compared to those receiving placebo; the relative risk of relapse for aripiprazole-treated patients was half that of placebo-treated patients (relative risk of relapse for aripiprazole:placebo = 0.503, p < 0.001). Physicians who elect to use Abilify for extended periods should periodically re-evaluate the long-term usefulness of the drug for individual patients.
In this long-term trial, there were no medically important differences in metabolic profile between patients receiving Abilify and placebo in mean change from baseline in prolactin, fasting glucose, triglyceride, high-density lipoprotein (HDL, or "good" cholesterol), low-density lipoprotein (LDL, or "bad" cholesterol) and total cholesterol measurements.
Abilify, the most recently approved treatment for schizophrenia in the United States, Mexico, Brazil, Puerto Rico, Peru, El Salvador and Australia, has been prescribed for more than 200,000 people in the United States. Abilify is available in 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets. Abilify is available by prescription only.
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.