MSD has received European approval for Sycrest (asenapine) sublingual tablets, an atypical antipsychotic for the treatment of moderate to severe manic episodes in bipolar I disorder in adults.
The approval was granted on the basis of review of efficacy data from a clinical trial programme that involved nearly 1,300 adults with bipolar mania.
The clinical trial programme included two similarly designed, randomised, three-week, double-blind, placebo- and active-controlled trials of asenapine. They demonstrated the superior efficacy of asenapine in reducing manic symptoms over three weeks when compared to a placebo.
A statistically significant difference between asenapine and placebo was observed on the second day.
Asenapine also maintained its safety and efficacy after 12 weeks of treatment.
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