Biotech Values

[apljack]

VNDA: Iloperidone

Iloperidone did not have the efficacy necessary to distinguish itself from more commonly used antipsychotics that have become the standard. The comparison drug in the Vanda study, Geodon, demonstrated similar efficacy with iloperidone, but iloperidone had inferior efficacy when compared to Risperdal (although I believe that this was simply a paper and pencil exercise of data comparisons). Geodon is rarely used as a clinical intervention for schizophrenia and other psychoses because of the Q-T prolongation issue. There is evidence that Q-T is an issue here as well.

http://www.ncbi.nlm.nih.gov/pubmed/18521091?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

I don't think that the FDA will approve a drug that has cardiac risks when there is a generic drug that is standard care (risperidone) that works better and doesn't have the same risks.

regards,

aj