Asenapine.

Asenapine is a novel psychopharmacological agent that binds with high affinity and specificity to numerous dopamine, serotonin, noradrenaline (norepinephrine) and histamine receptor subtypes. It is being developed for the treatment of schizophrenia and bipolar mania. In two randomized, controlled trials of asenapine monotherapy and in one randomized, controlled trial of adjunctive asenapine therapy in adult patients with bipolar I disorder, sublingual asenapine produced significantly greater reductions from baseline than placebo in clinician-assessed Young Mania Rating Scale (YMRS) total score at 3 weeks. In two randomized, controlled trials in adult patients with acute schizophrenia, treatment with asenapine reduced from baseline the clinician-assessed Positive and Negative Syndrome Scale (PANSS) total score to a significantly greater extent than placebo at 6 weeks. In schizophrenic patients with predominant, persistent, negative symptoms, asenapine at 26 weeks reduced the Negative Symptom Assessment (NSA-16) total score from baseline to an extent similar to that observed with olanzapine. Sublingual asenapine was generally well tolerated in clinical trials, with most treatment-emergent adverse events being of mild to moderate severity. Incidence rates of clinically significant weight gain, extrapyramidal symptoms, hyperprolactinaemia and alterations in glucose or lipid metabolism were generally low.

RCT Entities:   Population Interventions Outcomes