The European Commission has approved Sycrest (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The news came as no surprise, given that the European Medicines Agency's Committee for Medicinal Products for Human Use backed the drug in June.
The approval is based on a clinical trial programme which included nearly 1,300 patients with bipolar mania. Merck quoted John Cookson, a consultant psychiatrist in East London, as saying that "asenapine is a useful addition to the options available for treating mania, and side effects such as weight gain are likely to be fewer than with several of the alternative treatments.”
The drug, which Merck got hold of through its acquisition of Schering-Plough, is marketed as Saphris in the USA for schizophrenia as well as the European-approved indication.
The approval is based on a clinical trial programme which included nearly 1,300 patients with bipolar mania. Merck quoted John Cookson, a consultant psychiatrist in East London, as saying that "asenapine is a useful addition to the options available for treating mania, and side effects such as weight gain are likely to be fewer than with several of the alternative treatments.”
The drug, which Merck got hold of through its acquisition of Schering-Plough, is marketed as Saphris in the USA for schizophrenia as well as the European-approved indication.
-Links http://www.merck.com/
**Published in "Pharma Times"
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