Asenapine is a second-generation antipsychotic that is administered sublingually; the compound received regulatory approval two years ago by FDA for the acute treatment of schizophrenia in adults, and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. In the EMA, at the present, asenapine is approved only for the acute treatment of manic episodes associated with bipolar I disorder in adults. The aim of this review is to summarize published data in both the literature and regulatory documents on efficacy and safety of asenapine for the treatment of bipolar disorder.
