Asenapine maleate: a new drug for the treatment of schizophrenia and bipolar mania.

Schizophrenia and bipolar disorder are serious neuropsychiatric disorders with substantial health risks for patients that result in major socioeconomic burdens on society. Current therapeutic agents fail to adequately address patient needs in terms of efficacy, tolerability and treatment-related adverse events. Consequently there is an urgent need to develop more effective and better tolerated pharmacotherapies for improved treatment of these illnesses. Asenapine maleate is a novel drug recently approved by the Food and Drug Administration for treatment of acute schizophrenia and for manic or mixed episodes of bipolar I disorder with or without psychotic features in adults. It has a unique pharmacologic profile as it targets multiple dopamine, serotonin and adrenergic receptor subtypes with variable affinities. Such drug/receptor interactions contribute to the antipsychotic and antimanic efficacy of asenapine. Asenapine was effective in animal models predictive of antipsychotic activity and clinical trials indicate that it improves the symptoms of acute schizophrenia and bipolar mania, is well tolerated and has a favorable safety profile. This monograph provides an up to date review of the preclinical and clinical profiles of asenapine, including new clinical data in patients with schizophrenia and bipolar mania.