Positive bipolar and schizophrenia data for asenapine

US drug major Schering-Plough says that asenapine, a fast-dissolving, novel psychopharmacologic agent with a unique human receptor signature, was effective in two short-term bipolar mania studies with a nine-week extension and in two out of four short-term schizophrenia studies. According to data presented at the annual meeting of the American Psychiatric Association in Washington DC.

In the third short-term schizophrenia study, neither asenapine nor the active control differentiated from placebo; in the fourth study, asenapine did not differentiate from placebo, while the active control did. Overall, asenapine was well tolerated in the Olympia trial program, the firm noted. The US company acquired asenapine from last year's takeover of Dutch company Organon BioSciences (Marketletter November 26, 2007). The Food and Drug Administration is reviewing a New Drug Application for the drug in schizophrenia and acute manic or mixed episodes associated with bipolar I disorder.

In the bipolar I disorder trials, both asenapine and the active-control drug, Eli Lilly's Zyprexa (olanzapine), produced greater mean reductions in the Young Mania Rating Scale scores versus placebo after three weeks of treatment. Asenapine produced 13- and 14-point reductions in the YMRS total score from baseline to day 21 (p<0.05 versus placebo). The firm noted that olanzapine was also statistically superior to placebo and that there was no direct comparison between asenapine and Lilly's atypical antipsychotic, which earned $1.12 billion in first-quarter 2008. In a nine-week extension of the three-week trials, asenapine was non-inferior to olanzapine on change in YMRS.