Asenapine: a review of acute and extension phase data in bipolar disorder.

摘要: The second generation atypical antipsychotic, asenapine (Saphris), was approved by the US FDA (August 2009) for acute treatment of manic or mixed episodes with without psychotic features associated bipolar I disorder in adults as well schizophrenia. Asenapine exhibits a high affinity and antagonism at several serotonergic (5-HT(2A-C), 5HT(5A), 5HT(6), 5HT(7)), dopaminergic (D(2), D(3)), alpha-adrenergic (α(1) α(2)), histaminergic (H1, H2) receptor subtypes. is first antipsychotic formulated fast-dissolving, rapidly absorbed sublingual tablet. evaluated disorder, features. Two identically designed 3-week registration trials confirmed efficacy relative to placebo studies that included olanzapine an active control. placebo-subtracted rate EPS (excluding akathisia) 5% whereas akathisia 2%. clinically significant weight gain (≥7%) approximately during mania trials. A 9- extension trial indicated 19% patients will experience gain. Clinically metabolic abnormalities were not observed and/or can be somnolence (asenapine 24%, 6%) does appear changes vital signs, laboratory parameters, electrocardiographic changes. Bipolar depression recurrence prevention are required fully characterize this novel agent's position disorder.