The US Food and Drug Administration has approved iloperidone tablets (Fanapt) for the treatment of bipolar disorder in adults.
The latest approval was based on results of a phase 3 randomized, double-blind, placebo-controlled trial showing that patients withtreated with iloperidone had significantly better outcomes vs those who received placebo, with symptom improvement as early as 14 days after the initial dose.
Compared with placebo, iloperidone was associated with significant improvement of mania symptoms at week 4, with a mean reduction on the Young Mania Rating Scale of -4.0 . The treatment group also reported significant decreases on the on the Clinical Global Impressions-Severity scale (mean, -0.4;Statistically significant differences between iloperidone and placebo were observed as early as day 14 and continued through days 21 and 28.
Investigators leading the clinical trial noted that iloperidone and its primary metabolite, P88, possess high binding affinity for serotonin 5-HT2A and dopamine D2 and D3 receptors. Inhibiting these receptors is thought to contribute to the antimanic effects of iloperidone and other atypical antipsychotics, whether the bipolar mania is psychotic or nonpsychotic, they added.
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