Titan Announces Filing of Iloperidone NDA
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Titan Pharmaceuticals, Inc. (AMEX: TTP - News) today announced that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia. The application includes data from 35 clinical trials and more than 3,000 patients treated with iloperidone.
In Phase III clinical testing, iloperidone has been demonstrated to be potentially safe and effective in the treatment of schizophrenia in both the acute and the chronic setting. In addition, iloperidone demonstrated a potentially favorable side effect profile, with low potential for weight gain and induction of diabetes, low extrapyramidal symptoms including akathisia, and low incidence of sleepiness and effects on cognition. The NDA submission also contains pharmacogenetic data aimed to further improve the benefit/risk profile of iloperidone in the treatment of patients with schizophrenia. The NDA was submitted by Vanda Pharmaceuticals Inc. (NASDAQ: VNDA - News).
Upon commercialization of iloperidone, Titan will receive a royalty of between 8-10% on worldwide sales.
"We are very pleased that the iloperidone NDA has been filed. This is an important milestone for Titan, and a major step towards potentially providing schizophrenia patients with a meaningful and much needed therapeutic option," stated Dr. Marc Rubin, President and CEO of Titan Pharmaceuticals, Inc.
"Iloperidone may offer advantages to patients in need of alternative therapies," stated Dr. Louis R. Bucalo, Chairman of Titan Pharmaceuticals, Inc. "We are pleased with the continued progress of this development program."... |
