Novartis Pharmaceuticals Corporation has received approval from the U.S. Food and Drug Administration (FDA) to market Clozaril (clozapine) for the treatment of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are at chronic risk. This action by the FDA marks the first time that any medication has been approved for use in treatment of suicidal behavior. Although generic versions of Clozaril are available, FDA regulations provide Novartis with exclusive rights to market the new indication for a period of 36 months.

Novartis filed a supplemental New Drug Application (sNDA) in March 2002, for the indication based upon data from the International Suicide Prevention Trial (InterSePT), the first study ever to prospectively evaluate a medication in reducing the risk of suicidal behavior.

Suicide is the leading cause of premature death among patients with schizophrenia and schizoaffective disorder. Overall, these patients have approximately a 40% lifetime risk for suicide attempts and a 10% risk for a completed suicide. Suicidal behavior embodies symptoms ranging from suicidal thoughts, to suicidal plans and actual suicide attempts.

InterSePT was a prospective, multi-center, randomized study initiated in 1998 to compare the efficacy of two antipsychotic compounds, Clozaril and Zyprexa (olanzapine) one of the world's most widely prescribed antipsychotic medications, in reducing the risk of suicidal behavior among patients with schizophrenia or schizoaffective disorder. Clozaril reduced the risk of suicide attempts and hospitalizations to prevent suicide by about 25% compared to Zyprexa. These results were not related to the use of greater concomitant psychotropic medication as Clozaril-treated patients required fewer concomitant psychotropic medications such as antidepressants, anxiolytics, anti-psychotics and mood stabilizers. The safety profile observed in the study was consistent with the well-known characteristics of Clozaril.

Clozaril is still also indicated for the treatment of severely ill schizophrenic patients who fail to respond adequately to standard antipsychotic drug therapies.