KENILWORTH, N.J. Schering-Plough announced that new study results showed its drug candidate asenapine is more effective than a placebo in treating schizophrenia, according to the Associated Press.
The company said asenapine 5 mg was "significantly" more effective than a placebo at improving certain symptoms associated with acute schizophrenia. The 10 mg asenapine and haloperidol results were not as significant. Schizophrenia is a chronic, disabling brain disorder characterized by hallucinations, delusions and disordered thinking.
In the 448-person study, adult patients with schizophrenia received either asenapine 5 mg twice daily, asenapine 10 mg twice daily, haloperidol 4 mg twice daily or placebo for six weeks.
The primary goal was changes in total scores on the Positive and Negative Syndrome Scale after 42 days. PANSS measures positive symptoms, such as hallucinations and delusions, and negative symptoms, such as lack of emotion expression, associated with acute schizophrenia.
The PANSS score changes were "significantly greater" for asenapine at both doses and haloperidol versus placebo, the company said. Haloperidol and asenapine were not compared in the study.
On secondary measures of effectiveness, both doses of asenapine and haloperidol produced "significantly greater reductions" in PANSS positive subscale score compared with placebo. In addition, asenapine and haloperidol showed "significant changes" to the PANSS negative subscale score compared with placebo.