Objective: Asenapine is FDA-approved in adults for acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features or of schizophrenia. We summarize data from the asenapine Olympia clinical trials bipolar disorder program.
Methods: Two matched, double-blind, placebo-controlled 3-week trials (976 patients randomized to asenapine 5 or 10 mg BID, placebo, or olanzapine 5–20 mg QD) were followed by two double-blind extensions (totaling 1 year of asenapine monotherapy). In the 9- and 40-week extensions, patients originally receiving placebo were switched to asenapine and assessed for safety only. Additional trials assessed asenapine 5 or 10 mg BID as an adjunct to lithium or valproate. The primary outcome was change from baseline on the Young Mania Rating Scale (YMRS).
Results: Asenapine monotherapy produced 11- to 12-point reductions in YMRS score at week 3 (P<0.05 vs placebo). In the monotherapy extensions, YMRS score reductions for asenapine and olanzapine were 24 points at week 12 and 28–29 points at week 52. Further, there were no significant differences in YMRS response or remission rates, suggesting asenapine was at least as effective as olanzapine. Sedation and somnolence were common with both treatments. Extrapyramidal symptoms were more common with asenapine; clinically significant weight gain was more common with olanzapine. YMRS score reductions of 10 and 13 points (both P<0.05 vs placebo) were observed with adjunctive asenapine at weeks 3 and 12, respectively.
Conclusion: Asenapine was effective and well tolerated as monotherapy and adjunctive therapy for bipolar I disorder.