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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.

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Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

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