Strong Ph III data for Organon's asenapine

Dutch drugmaker Organon's bipolar I disorder and schizophrenia medicine asenapine was more effective than placebo in treating acute manic and mixed episodes associated with bipolar I disorder, according to new Phase III study data presented at the annual meeting of the American Psychiatric Association, held in San Diego.

In the three-week study, patients treated with either asenapine or Eli Lilly's leading schizophrenia drug Zyprexa (olanzapine) experienced significant improvements in acute mania symptoms versus those on placebo. Both drugs demonstrated superiority vs placebo by the second day of treatment and maintained this benefit throughout the trial. Robert Hirschfeld, professor of psychiatry and behavioral sciences at the USA's University of Texas Medical Branch, said that "the results of this trial suggest that asenapine is an attractive option for the acute treatment of mania because of its rapid onset of action and modest side effect profile."

The primary efficacy endpoint in the Phase III, double-blind, international trial was a reduction in Young Mania Rating Scale (YMRS) total score at day 21. At day two both drugs provided greater mean reductions in YMRS scores vs placebo (-3.0 and -3.4, respectively, vs -1.5; p<0.008 for asenapine, p<0.001 for olanzapine). At the end of the trial, both active treatments continued to produce significant mean improvements in mania symptoms vs placebo (-10.8 and -12.6, respectively, vs -5.5; both p<0.0001).