Novartis reports positive clinical phase III results for investigational schizophrenia drug Zomaril™

26.09.2000

Basel, 25 September 2000 – Novartis today announced positive safety and efficacy data from a large scale, controlled, phase III study of Zomaril™ (iloperidone), a new drug currently in development for the treatment of schizophrenia. The global trial involved more than 600 patients at more than 40 centers throughout the US, Europe, Canada, Australia and South Africa and was designed to assess the ability of Zomaril to control safely and effectively the positive and negative symptoms in schizophrenia patients.

"We are further encouraged by these results and are well on track with the development of Zomaril as a novel therapy for schizophrenia" said Joerg Reinhardt, Head of Novartis Pharma Development.

The results demonstrated that both dose levels of Zomaril used in the study achieved a highly statistically significant reduction in the symptoms of schizophrenia as assessed by the Brief Psychiatric Rating Scale. These findings were also supported by highly statistically significant improvements in the total score for the Positive and Negative Syndrome Scale with both dose levels. In addition, the study confirmed that Zomaril possesses an excellent tolerability profile with no extrapyramidal symptoms, little weight gain and no effect on serum prolactin. Full details of the study results will be presented at international psychiatry congresses next year.

The study is part of a program called 'ReALIZe' (Research to Assess the Long-term Impact of Zomaril), which comprises seven different studies being conducted at some 300 centers around the world. To date, more than 3200 patients have participated in ReALIZe studies, which are designed to evaluate the safety and efficacy of Zomaril against various end-points.

https://www.chemie.de/news/92/novartis-reports-positive-clinical-phase-iii-results-for-investigational-schizophrenia-drug-zomaril.html