FDA gave green signal to Schizophrenia drug from Titan
Food and Drug Administration finally gave green signal to antipsychotic drug iloperidone as a treatment for adult schizophrenia on Wednesday.
Titan said Iloperidone, a drug Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) will market as Fanapt, will be available in pharmacies later this year.
Last summer Titan's Parkinson's disease treatment, Spheramine, failed a clinical trial. After which the rights to the drug were sold to Vanda Pharmaceuticals. Vanda included ziprasidone (Geodon) as the active comparator and conducted new trails.
In a four-week trial including 593 patients, iloperidone was as effective as ziprasidone in improving scores on the Positive and Negative Syndrome Scale (PANSS). Both drugs did better than placebo.
Titan will have 8 percent royalties on annual net sales up to $200 million, and 10 percent on annual net sales of Fanapt above $200 million.
Titan President Sunil Bhonsle said: "We congratulate the management and employees of Vanda on their dedication and perseverance in obtaining FDA approval of Fanapt."
