Singapore, May 9, 2008: The Food and Drug Administration has approved updated labeling for Abilify, a drug made jointly by Bristol-Myers Squibb and Japan’s Otsuka Pharmaceuticals.

 

In a prepared release, BMS said the US Food and Drug Administration approved updated labeling for Abilify (aripiprazole) as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults.

 

Abilify has been approved as monotherapy for the treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults since September 2004.

 

In addition to this new indication, the FDA also approved a new recommended starting and target dose of 15 mg daily for Abilify monotherapy in the treatment of Bipolar I Disorder in adults.

 

The approval of Abilify used in combination with lithium or valproate is based on results from a six-week, randomized, double-blind, placebo-controlled study in adults with manic or mixed episodes of Bipolar I Disorder who had an inadequate response to a two-week, lead-in phase of mood stabilizer monotherapy (lithium or valproate).

 

"Expanding the clinical use of Abilify gives patients with Bipolar I Disorder a new treatment option," said Elliott Sigal, Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb.

 

"Our mission at Otsuka is to develop products to their fullest potential," said Hiromi Yoshikawa, Chairman and Chief Executive Officer, Otsuka America Pharmaceutical. "The approval of this new indication for Abilify provides another option for physicians that helps address the needs of their patients."