Novartis Zomaril
Executive Summary
Schizophrenia drug iloperidone shows "at 16 mg level a significantly different efficacy level as compared to placebo," Novartis said during an Oct. 11 teleconference. "The Pink Sheet" (Oct. 16, p. 14) incorrectly reported that the comparator agent in the trial was J&J's Risperdal. Novartis licenses Zomaril from South San Francisco-based Titan Pharmaceuticals. "Novartis' timeline for NDA submission for Zomaril is fourth quarter 2001," Titan said
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Novartis plans to start additional studies for iloperidone in the fourth quarter to facilitate regulatory review of the schizophrenia drug. Studies will investigate once-a-day dosing and will include at least one switch study from comparator agents. Data from the six-week active phase studies will be included in the NDA submission planned for the fourth quarter of 2002. Novartis' previous timeline for NDA submission was the fourth quarter of 2001 (1"The Pink Sheet" Oct. 23, 2000, In Brief). The brand name for iloperidone will also be changed from Zomaril in response to FDA's concerns about possible confusion with another product: Novartis says "Zom" will still be part of the prefix. Novartis is developing the drug in collaboration with Titan
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