New Study Results Show Asenapine More Effective Than Placebo in the Treatment of Acute Sch...(mgand 10 mg and haloperidol produced sig...),Health

Date:12/17/2007

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.

About schizophrenia

Schizophrenia is a chronic, disabling brain disorder characterized by hallucinations, delusions, and disordered thinking. About 24 million people worldwide (or seven in every 1,000 adults in the population) have schizophrenia (1), including more than two million people in the U.S. (2) and more than four million people in Europe (3). People with schizophrenia may hear voices other people don't hear or may believe others
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SOURCE Schering-Plough Corporation Copyright©2007 PR Newswire. All rights reserved

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