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news.Schering-Plough Corporation has announced new study results that demonstrated that asenapine, a fast-dissolving, sublingual tablet being developed for treatment of schizophrenia, was more effective than placebo and well tolerated in treating patients with acute schizophrenia.
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According to the results, asenapine 5mg twice daily and 10mg twice daily were both significantly more effective than placebo at improving patient positive and negative syndrome scale (PANSS) total scores.
In the study, 448 adult patients with schizophrenia received either asenapine 5mg twice daily, asenapine 10mg twice daily, haloperidol 4mg twice daily (active comparator), or placebo for six weeks. The primary endpoint was changes in PANSS total score from baseline to day 42.
PANSS score changes were significantly greater for asenapine 5mg twice daily, asenapine 10mg twice daily and haloperidol versus placebo (-21.3, -19.4, -20 and -14.6, respectively) based on mixed model for repeated measurements (MMRM) analysis. On secondary efficacy measures, asenapine 5mg and 10mg and haloperidol produced significantly greater reductions in PANSS positive subscale score versus placebo (-7.5, -6.9 and -7.3 versus -5, respectively).
In addition, asenapine 5mg and 10mg and haloperidol demonstrated significant changes to the PANSS negative subscale score versus placebo (-4.5, -4.3 and -4.2 versus -3, respectively) and on the PANSS general psychopathology subscale score (-9.6, -8.5 and -8.6 versus -6.8, respectively).