“Otsuka remains committed to developing products that are able to meet their fullest potential while helping physicians provide effective care for their patients,” said William H. Patients should be periodically reassessed by their physician to determine the continued need for maintenance treatment.”
“Because Bipolar Disorder is a lifelong and recurrent illness, this labeling update provides physicians with the option to prescribe ABILIFY as an add-on to either lithium or valproate as a long-term treatment to help manage symptoms of Bipolar I Disorder. “Patients with Bipolar I Disorder often experience cycles of severe mood swings rather than a single episode 1,” said John Tsai, M.D., vice president, U.S.
ABILIFY is not approved for the treatment of patients with dementia-related psychosis. Elderly patients treated with antipsychotic drugs are at an increased risk of death. ABILIFY has a boxed warning regarding increased mortality in elderly patients with dementia-related psychosis.
ABILIFY is also approved as monotherapy for the acute treatment of manic or mixed episodes associated with Bipolar I Disorder and for the maintenance treatment of Bipolar I Disorder. Food and Drug Administration (FDA) has approved ABILIFY ® (aripiprazole) as an adjunct to the mood stabilizers lithium or valproate for the maintenance treatment of Bipolar I Disorder.ĪBILIFY was approved as an adjunct to lithium or valproate for the acute treatment of manic or mixed episodes associated with Bipolar I Disorder in May 2008. & TOKYO-(BUSINESS WIRE)- Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd., announced today that the U.S. Data from 52-week maintenance trial showed superiority of adjunctive ABILIFY versus adjunctive placebo on primary study endpoint