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H. Lundbeck A/S (Lundbeck) today announced the launch of Sycrest® (asenapine) sublingual tablets (5 mg, 10 mg) for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults in Europe with Denmark being the first country to launch.
Sycrest was licensed from Merck & Co. (known as MSD outside the United States and Canada) in October 2010, and Lundbeck was granted exclusive commercial rights in all markets outside the United States, Japan and China.
On September 1 2010, Sycrest received European Union (EU) approval from the European Medicines Agency (EMA) based on clinical data showing significant remission (versus placebo) in bipolar patients with manic and mixed episodes.
Adult bipolar I disorder in the EU is still highly under-diagnosed and under-treated. In addition change in treatment schedule is common due to lack of efficacy or safety and tolerability concerns.
Sycrest represents another treatment option for patients within this under-treated population.
Lundbeck expects to launch the product in additional approximately 15 European and international markets during 2011
“We are extremely pleased that we are now ready to start the roll-out of Sycrest in Europe as it will be an important product in Lundbeck’s portfolio of innovative CNS products,” said Executive Vice President Stig Løkke Pedersen, Head of Commercial Operations. He continues: “Sycrest will be an important, new choice for healthcare providers to help patients manage the symptoms of bipolar I disorder.”