[Asenapine in bipolar disorder: efficacy, safety and place in clinical practice]

Abstract

Asenapine is a new second-generation antipsychotic (SGA) approved in September 2010 by the European Medicines Agency for the treatment of bipolar disorder. It was significantly more effective than placebo in acute mania or mixed episodes as monotherapy or adjunctive therapy to mood stabilizers (lithium or valproate). Early improvement was seen at day-2 (significant difference with placebo) and was strongly associated with week-3 response and remission. These suggest that the observation of an early improvement in the first week may be clinically an useful tool for individual treatment adjustment during the early course of treatment. Post-hoc analyses of asenapine studies showed significantly better effects on improving depressive symptoms associated with manic symptoms, and physical health related quality of life dimensions as compared to placebo. Asenapine differs from the other SGAs by a good tolerability profile, in particular in terms of metabolic profile. However, it seems to have a significant though moderate link with the occurrence of sedation. This new tolerance profile greatly broadens the scope of SGAs and supports the view of some authors that the term SGA is now outdated. Other therapeutic perspectives of asenapine are being assessed, in particular in specific population (pediatric and elderly patients).