>> The fact that they have an idea about some QT elongation should cause the FDA to, in the least, force more study of these effects. IMO, this could delay/hold any approval. <<
I’d like to add some color on Iloperidone, the drug Novartis and Titan Pharmaceuticals tried to develop for schizophrenia. In mid-2002, Novartis had already completed one phase-3 trial showing statistically significant efficacy at the higher of two doses, and they were about to launch a second phase-3 trial needed for FDA approval. However, the FDA was spooked by the drug’s QTc-prolongation and demanded an additional safety study to focus on that issue. After conducting the QTc safety study, Novartis dropped further development of the product even though the data showed that Iloperidone produced QTc-prolongation that was equivalent to that of Geodon, an approved drug for the same indication. The point here is that the drug business is a business and Novartis reasoned that the QTc-prolongation, although modest clinically, was a killer economically. FWIW
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