Aripiprazole (Abilify) approved as adjunctive therapy for bipolar disorder

May 12, 2008

Aripiprazole receives new indication as adjunct to lithium or valproate

A new indication for aripiprazole (Abilify, Bristol-Myers Squibb/Otsuka) has been approved by the Food & Drug Administration. The drug can now be used 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. The regulatory nod came after review of a study of 384 patients who received stabilized doses of lithium or valproate to achieve therapeutic blood levels. Patients who demonstrated an inadequate response were then randomized to receive either aripiprazole (15 mg or 30 mg) or placebo. Add-on aripiprazole demonstrated statistically significant improvement in symptoms when compared with the adjunctive placebo (p=0.002). The FDA also approved changes to the aripiprazole label to include new pharmacokinetic information on the co-administration of 10 mg/day to 30 mg/day with 100 mg/day lamotrigine. A ?no dosage adjustment of lamotrigine is required when aripiprazole is added to lamotrigine? statement was also added. Aripiprazole was previously approved in 2004 as a monotherapy for the treatment of manic or mixed episodes associated with bipolar I disorder in adults.To see more Daily News articles, click here. To go to the Drug Topics homepage, click here.