Vanda"s Iloperidone: Lemonade or Lemon

Implications: 1. Iloperidone has demonstrated efficacy in treating positive and negative symptoms of schizophrenia and also has a favorable safety profile. 2. Vanda has utilized pharmacogenetic studies to identify a group of schizophrenic patients that will benefit from this agent that binds to a number of serotonin and dopamine receptors. 3. Two out of three previous Novartis Iloperidone trials were failed trials but they utilized low to medium doses of Iloperidone.

Analysis: There are a couple of questions that must be answered before jumping on or avoiding the Iloperidone bandwagon. The first is how practical will it be to do pharmacogenetic testing before prescibing an antipsychotic? This will partially be determined by the cost and accessability of such a test. Will third party payers stonewall such a test if they view it as being too pricey? The second question is whether this drug will show postmarking efficacy. Vanda has demonstrated efficacy at higher doses but Novartis did not obtain the same results using lower to middle range doses. Physicians tend to utilize lower doses of a new agent when it is first introduced; the lack of early clinical success using lower than desired doses could potentially deflate early sales of this agent. It took several years for Pfizer to straighten out the dosing issues regarding Geodon. Vanda does not have the same resources as Pfizer and might not be able to fight this impending tough battle.