Knobias Clip Report (07-26-2008) TTP/VNDA
Submitted By Knobias ClipReport
TTP/VNDA: Not Approvable Letter from FDA for Iloperidone in Schizophrenia
By Fain Hughes, fhughes@knobias.com
Titan Pharmaceuticals, Inc. (TTP) announced that Vanda Pharmaceuticals, Inc. (VNDA) has received a not approvable letter for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia, from the FDA. Vanda, the sub-licensee for iloperidone, is responsible for the development and commercialization of this product.
The FDA stated that Vanda had demonstrated the effectiveness of iloperidone at 24 mg/day in the 3101 study for which the company reported results in December, 2006, and that the efficacy was similar to the active comparator, ziprasidone (Geodon(R), Pfizer Inc.). In addition, the FDA also stated that iloperidone was superior to placebo in patients with schizophrenia at doses of 12-16 mg/day and 20-24 mg/day in a prior study. However, the FDA expressed concern about the efficacy of iloperidone in patients with schizophrenia relative to the active comparator, risperidone (Risperdal(R), Johnson & Johnson), used in prior studies. The FDA indicated that it would require an additional trial comparing iloperidone to placebo and including an active comparator such as olanzapine (Zyprexa(R), Eli Lilly & Company) or risperidone in patients with schizophrenia to demonstrate the compound’s efficacy further. The FDA also stated that it would require Vanda to obtain additional safety data for patients at a dose range of 20 to 24 mg/day.
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