FDA Approves Iloperidone for Bipolar Disorder

The US Food and Drug Administration (FDA) has approved iloperidone tablets (Fanapt) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Iloperidone is a mixed dopamine D2/serotonin 5-HT2A receptor antagonist and belongs to the class of atypical antipsychotics. It was first approved by the FDA in 2009 for the acute treatment of schizophrenia in adults. 

The latest approval was based on results of a phase 3 randomized, double-blind, placebo-controlled trial showing that patients with bipolar mania treated with iloperidone had significantly better outcomes vs those who received placebo, with symptom improvement as early as 14 days after the initial dose.

Source: MEDspace