Lundbeck, an international pharmaceutical company, has announced that Sycrest (asenapine) is being launched in the UK for treating moderate to severe manic episodes associated with bipolar I disorder in adults.
Sycrest, an antipsychotic, is a sublingual tablet. The two similarly-designed, three-week double-blind randomised placebo and active-controlled (olanzapine) monotherapy trials have demonstrated that Sycrest showed efficacy as early as day two with a reduction of manic symptoms associated with bipolar I disorder in adults over three weeks compared with the placebo.
The post-hoc analyses of the three-week trials also reported that Sycrest, but not olanzapine, improved depressive symptoms over the placebo at day seven. The efficacy of Sycrest as adjunctive therapy to the mood stabilisers lithium or valproate was also demonstrated in a 12-week, placebo-controlled trial involving 326 patients who were partially non-responsive to lithium or valproate monotherapy for two weeks at therapeutic serum levels. The study concluded that the use of Sycrest as adjunctive therapy improved reduction of manic symptoms compared to lithium at week three and week 12.
The short and long-term studies showed that Sycrest reported a mean weight gain of 0.8kg, and observations from a 12-week study showed the mean weight change to be 1.9kg versus 4.1kg seen in olanzapine patients.
Sane CEO Marjorie Wallace said the people with bipolar disorder experiencing manic episodes will have the option of the new treatment, which offers hope for effective management of distressing symptoms. Bipolar I disorder, also known as manic depressive disorder, is a long-term condition characterised by alternations between two poles of extreme moods - mania and depression, or a combination of both.
Headquartered in Denmark, Lundbeck is engaged in the research, development, production, marketing and sale of products for treating depression and anxiety, schizophrenia, insomnia and epilepsy, and Huntington's, Alzheimer's and Parkinson's diseases.