Asenapine More Effective In Treatment Of Acute Schizophrenia

Schering-Plough reported on 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.

According to the results, asenapine 5 mg twice daily and 10 mg twice daily were both significantly more effective than placebo at improving patient Positive and Negative Syndrome Scale (PANSS) total scores. PANSS is a measure of positive symptoms (e.g., hallucinations and delusions) and negative symptoms (such as lack of emotion expression) associated with acute schizophrenia.

"Patients with schizophrenia and their physicians need to have a variety of treatment options available for the symptoms of this disorder because many patients stop taking their medication," said John M. Kane, M.D., Chairman of Psychiatry, the Zucker Hillside Hospital in Glen Oaks, NY. "A new therapy that is both effective and well-tolerated would be an important addition to the treatment options currently available."

Study overview

In the study, 448 adult patients with schizophrenia received either asenapine 5 mg twice daily, asenapine 10 mg twice daily, haloperidol 4 mg 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 5 mg twice daily, asenapine 10 mg twice daily and haloperidol versus placebo (-21.3, - 19.4, -20.0 and -14.6, respectively) based on MMRM analysis (Mixed Model for Repeated Measurements). On secondary efficacy measures, asenapine 5 mg and 10 mg, and haloperidol produced significantly greater reductions in PANSS positive subscale score vs. placebo (-7.5, -6.9 and -7.3 vs. -5.0, respectively). In addition, asenapine 5 mg and 10 mg, and haloperidol demonstrated significant changes to the PANSS negative subscale score vs. placebo (-4.5, -4.3 and -4.2 vs. -3.0, respectively) and on the PANSS general psychopathology subscale score (-9.6, -8.5 and -8.6 vs. -6.8, respectively).

Significantly more patients on both asenapine 5 mg and 10 mg, and haloperidol demonstrated reductions in PANSS total score of greater than or equal to 30 percent (PANSS responders) vs. placebo (55 percent, 49 percent and 43 percent vs. 33 percent, respectively). Changes on the Clinical Global Impression-Severity of Illness (CGI-S) scale for asenapine 5 mg and 10 mg, and haloperidol were higher than for placebo (-1.2 , -1.1 and -1.2 vs. -0.8, respectively).

The most commonly reported adverse events (AEs) were insomnia, oral hypoesthesia (reduced sense of touch), and akathisia (restlessness) for asenapine (for both doses); akathisia, Parkinson-like symptoms, and insomnia for haloperidol. The incidence of clinically-significant weight gain, as well as changes in lipid and blood-sugar levels in this trial were small and not different among the treatment groups and placebo. The incidence of extrapyramidal symptoms reported as an adverse event was 15 percent and 18 percent for asenapine (5 and 10 mg, respectively), 34 percent for haloperidol, and 10 percent for placebo.