Asenapine: A Novel Atypical Antipsychotic Agent for Schizophrenia and Bipolar I Disorder

Abstract

Objective:

To review the literature regarding asenapine, a recently approved atypical antipsychotic, and to evaluate its safety and efficacy profile.

Data Sources:

Primary literature was identified by conducting a MEDLINE search (1950–June 2010). English-language articles were searched using the key words asenapine, Saphris, schizophrenia, and bipolar disorder. All data were reviewed for clinical trials evaluating the safety and efficacy of asenapine. Data were also obtained directly from the manufacturer.

Study Selection and Data Extraction:

English-language articles on studies conducted in humans were reviewed.

Data Synthesis:

Asenapine is a novel atypical antipsychotic agent available as a treatment option for patients with schizophrenia, as monotherapy for the acute treatment of bipolar I manic or mixed episodes, and as adjunctive therapy with either lithium or valproate for the acute treatment of bipolar I manic or mixed episodes. Compared with other atypical antipsychotic agents, asenapine has a favorable adverse effect profile in terms of weight gain and metabolic disorders. Multiple studies have established its efficacy and safety profile. Asenapine has been shown to be superior to placebo in 4 clinical trials in patients with schizophrenia and in 2 clinical trials in patients with bipolar I disorder. Two studies comparing asenapine with olanzapine found asenapine to be similar in efficacy, 1 found olanzapine to be more effective, and 1 trial found asenapine to be associated with more adverse effects than olanzapine. This new agent is formulated as a sublingual tablet and is administered at either 5 or 10 mg twice daily. Common adverse effects reported include extrapyramidal symptoms, somnolence, sedation, and dizziness.

Conclusions:

Asenapine offers a viable treatment option for the acute treatment of patients affected by schizophrenia and bipolar I disorder. Future studies are needed to compare asenapine directly against other atypical antipsychotics to determine its appropriate place in therapy.