Iloperidone Approved as “Second-Generation” Benefits Debated

The FDA recently approved iloperidone (Fanapt, Vanda Pharmaceuticals) for the treatment of schizophrenia, reversing a July 2008 determination that the New Drug Application (NDA) was “not approvable.” An FDA spokesperson explained in an interview in Forbes (May 8), “Vanda provided the FDA with additional data and arguments that led us to reinterpret results of several of their studies.”

The favorable judgment culminated a circuitous product development path. The compound had been developed by Hoechst Marion Roussel, but the rights were sold to Titan Pharmaceuticals in 1997, and then to Novartis in 1998, before Vanda Pharmaceuticals acquired them in 2004. Vanda succeeded in garnering regulatory approval, in large part by redesigning the clinical trials supporting the NDA.

Rather than comparing the efficacy of iloperidone with risperidone and haloperidol, which had not previously favored iloperidone, the new trials compared iloperidone with placebo and used ziprasidone as an active control. In this design, the active agents were shown to have comparable efficacy in improving symptoms measured on the 30-item Positive and Negative Syndrome Scale (PANSS) and were both statistically superior to placebo.

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FDA Reverses Earlier Decision, Approves Schizophrenia Drug

The new antipsychotic medication has pharmacological and clinical profiles similar to those of other second-generation drugs on the market and appears to carry comparable risks.

After being turned down by the Food and Drug Administration (FDA) almost a year ago, iloperidone has gained approval for the acute treatment of schizophrenia in adult patients.

Iloperidone is a second-generation antipsychotic (SGA) medication mixed antagonism for dopamine D2 and serotonin 5HT2A receptors and is owned by Vanda Pharmaceuticals.

In two randomized, placebo-controlled, phase-3 trials in patients with schizophrenia, iloperidone was found more efficacious than placebo in reducing schizophrenia symptoms among study subjects.

In one trial, 604 patients with schizophrenia received iloperidone 24 mg/day, placebo, or ziprasidone for four weeks, with patients on iloperidone showing significant benefits in Positive and Negative Syndrome Scale total scores compared with placebo. In the other trial, involving 706 patients, iloperidone was compared with placebo and risperidone. After six weeks, the drug was superior to placebo in the reduction of total score on the Brief Psychiatric Rating Scale. The company did not release any data on how iloperidone compared with either ziprasidone or risperidone on efficacy indicators.

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Iloperidone Results Show Favorable Akathisia Profile

According to study results presented today at the 2007 American Psychiatric Association annual meeting, iloperidone, an investigational atypical antipsychotic, was shown to have a favorable akathisia profile.

Akathisia is a debilitating sensation of restlessness that manifests as an inability to sit still is a frequent side effect of antipsychotic medications. Iloperidone is being studied by Vanda Pharmaceuticals.

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