HAMILTON, N.J., Sept. 14 /PRNewswire/ -- MedAvante, Inc., the leader in centralized expert evaluation of CNS disorders, announced today that the U.S. Food and Drug Administration (FDA) has approved the first New Drug Application (NDA) for a psychiatric medication including primary outcome data collected by MedAvante centralized raters.
Johnson and Johnson Pharmaceutical R&D, a Johnson & Johnson company, submitted the NDA for the drug paliperidone palmitate, now known as Invega Sustenna®, for the acute and maintenance treatment of schizophrenia.
In one of the NDA multicenter studies, primary outcome measures were pooled from two groups, one within and one outside the United States. MedAvante centralized raters administered the assessments for the U.S. portion of the study. Outside the US, local site-based raters administered the assessments. The study, including the use of MedAvante Centralized Ratings, was recently described in the Journal of Clinical Psychopharmacology(1) and referenced in the FDA's Summary Basis of Approval (SBA).*
"The approval of this drug, based on a data package that included the use of centralized psychiatric raters, demonstrates the increasing regulatory acceptance of this tool," said Scott Gottlieb, MD, former Deputy Commissioner of the FDA and member of the MedAvante Board of Directors.
"Other areas of drug regulation have shown a preference for centralizing the assessment of subjective endpoints to achieve greater standardization, consistency, and quality in the data," said Dr. Gottlieb. "Now there is every reason to believe that the subjective and variable manner in which patients in CNS clinical trials have historically been evaluated by site-based raters will become subject to similar improvements."
MedAvante's proprietary methodology, Remote Centralized Ratings™, systematically addresses the sources of bias that can make it difficult to separate placebo response from true
|SOURCE MedAvante, Inc.|
Copyright©2010 PR Newswire.
All rights reserved