The U.S. Food and Drug Administration (FDA) has granted approval to Vanda Pharmaceuticals, Inc.'s Fanapt® (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adult patients. This approval marks an expansion of Fanapt's therapeutic use, as it has been utilized as an atypical antipsychotic agent for the acute treatment of schizophrenia since its initial FDA approval in 2009.
The decision to approve Fanapt® for bipolar I disorder was supported by data from a pivotal clinical trial that randomized approximately 400 participants. The study's primary endpoint, which was evaluated at Week 4 of treatment, demonstrated a statistically significant improvement in manic symptoms in patients treated with iloperidone compared to placebo. Further details regarding the specific efficacy measures and statistical significance (e.g., p-values, confidence intervals) were not disclosed in the source document.
Iloperidone's mechanism of action involves antagonism of dopamine D2 and serotonin 5-HT2A receptors, which is characteristic of atypical antipsychotics. This dual action is believed to contribute to its efficacy in managing both positive and negative symptoms of psychotic disorders. While the source document does not provide specific details on the dosing regimen or administration route for bipolar I disorder, it is likely to be similar to that used in schizophrenia treatment, with adjustments made based on individual patient needs and tolerability.
The approval of iloperidone offers an additional treatment option for adults experiencing manic or mixed episodes of bipolar I disorder. Bipolar I disorder is a chronic mental illness characterized by recurrent episodes of mania and depression, affecting approximately 1% of the adult population worldwide. Effective management of acute manic episodes is crucial to prevent hospitalization and improve long-term outcomes for patients with bipolar I disorder.
