GEN Exclusives

More »

GEN News Highlights

More »
Sep 2, 2010

EU Sanctions Merck & Co.'s Sublingual Bipolar Disorder Drug Sycrest

  • Merck & Co's non-U.S. business, MSD, reported approval throughout the EU for Sycrest®, a sublingual asenapine drug for treating moderate to severe manic episodes in adult patients with bipolar I disorder. Sycrest was first approved in the U.S. in 2009, where it is marketed as Saphris® for the treatment of schizophrenia and mania in bipolar disorder.

    EU approval was based on data from trials involving some 1,300 patients with bipolar mania. Studies included two montherapy trials comparing Sycrest with olanzapine and placebo and a 326-patient study evaluating the drug as  adjuctive therapy to lithium or valproate.

    The results of the 12-week placebo-controlled trial found that giving asenapine to patients who were partially nonresponsive to lithium or valproate monotherapy resulted in improved reduction of manic symptoms compared to what either approved drug could achieve when given alone.

Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content


GEN Jobs powered by connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
More »

Be sure to take the GEN Poll

Patient Access to Genetic Information

Do you think patients have the absolute right to gain access to their own genetic information from medical or clinical laboratories?

More »