Iloperidone Phase III Clinical Data Demonstrate Efficacy and Favorable Safety and Tolerability Profile
News Dec 14, 2007
Titan Pharmaceuticals, Inc. has announced that data from four Phase III efficacy and safety trials demonstrate that iloperidone, an investigational atypical antipsychotic, is associated with greater improvements in the symptoms of schizophrenia versus placebo and has a favorable safety and tolerability profile.
These results were included as part of the recently filed New Drug Application (NDA) for iloperidone and were presented by Titan’s corporate partner, Vanda Pharmaceuticals, Inc., for the first time this week at a major psychiatric congress. The U.S. Food and Drug Administration (FDA) accepted the NDA submitted by Vanda for marketing approval on November 26, 2007.
The final Phase III study conducted by Vanda evaluated the efficacy of iloperidone versus placebo in patients with schizophrenia. The study was a randomized, double-blind, placebo-controlled, multi-center, four-week inpatient study that enrolled 604 patients.
Following fixed-dose titration, inpatients were randomized to receive iloperidone at 24 mg/day, ziprasidone at 160 mg/day, or placebo. Patients treated with iloperidone had significantly greater improvements in Positive and Negative Syndrome Scale-Total (PANSS-T) scores than those on placebo and had PANSS-T improvement comparable to ziprasidone.
Iloperidone and ziprasidone showed similarly low effects on glucose, cholesterol, triglyceride and prolactin levels compared to placebo, and iloperidone was also associated with a favorable profile on the Extrapyramidal Symptoms Rating Scale (ESRS) versus placebo.
Exposure to Low Levels of BPA during Pregnancy Can Lead to Altered Brain DevelopmentNews
New research in mice provides an explanation for how exposure to the widely used chemical bisphenol A (BPA) during pregnancy, even at levels lower than the regulated “safe” human exposure level, can lead to altered brain development and behavior later in life.READ MORE
Moving Toward a Future Free of Drug-Induced Hearing LossNews
A new special publication orchestrated by five of the nation's leading hearing experts compiles the latest research into hearing loss caused by drugs and solvents - how it occurs, how to treat it, and how to prevent it.READ MORE
3-D Tissue Model of Developing Heart Could Aid Drug Safety Testing for Pregnant WomenNews
Parents and doctors often have to consider the mother's health as well as the potential risk regarding how medication could affect their baby. Researchers have developed a process to make a 3D tissue model that could mimic early stage human heart development, which could aid drug safety testing and help determine a drug's effects on fetal development.READ MORE
Comments | 0 ADD COMMENT
World Congress on Advanced Pharmacy and Clinical Research
Jul 16 - Jul 17, 2018
World Congress on Pathology and Laboratory Medicine
Sep 10 - Sep 11, 2018