Asenapine – a novel second generation antipsychotic drug
Krzysztof Artur Kucia, Aneta Sikora

Asenapine is a new antipsychotic drug, approved by the FDA in 2009 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. The trade name of asenapine in USA is Saphris and proposed trade name in EU is Sycrest. Intended in 2010 European registration comprise analogous indications except mixed episodes associated with bipolar I disorder. Asenapine has showed high affinity and specificity to numerous dopamine, serotonin, noradrenaline and histamine receptors. Both of two major metabolites of the drug are inactive, and the mean elimination half-life is approximately 24 hours. Asenapine is recommended to be administered as a sublingual tablets, ensuring optimal and rapid absorption. The recommended dose in schizophrenia is 5 mg given twice daily, the recommended starting dose in bipolar disorder is 10 mg twice daily. Clinical trials with asenapine proved significantly its efficacy in reduction of positive and negative symptoms of schizophrenia as well as symptoms of manic episodes. In all clinical trials, it was generally well tolerated. The most often adverse events were insomnia, somnolence, headache and weight increased, reported as mild or moderate.