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FDA Approves NDA That Includes Psychiatric Data Collected by Centralized Raters
Date:9/14/2010

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 drug response during many types of CNS clinical trials.

According to Scott A. Reines MD, PhD, a senior scientific advisor to MedAvante and former Senior Vice President for Clinical Neuroscience at J&J Pharmaceutical R&D during the conduct of the paliperidone palmitate program, "One of the major obstacles in schizophrenia studies has been the high placebo response frequently observed in US clinical trials.  Centralized ratings were utilized in the paliperidone palmitate study in order to help address this issue."  

"Working with MedAvante in this study was well worth the effort. It helped to provide external validation in the measurements of efficacy for paliperidone," said Ronald Brenner, MD, and Principal Investigator at Neurobehavioral Research, Inc. in Cedarhurst, New York.

"Because MedAvante centralized raters are continuously trained, monitored, and calibrated as a single, standardized cohort, they are more effective in determining patient diagnosis and eligibility according to protocol, more accurate in setting accurate baseline scores, and better able to raise the level of inter-rater reliability," said Paul Gilbert, Chief Executive Officer of MedAvante. "Achieving this NDA is an important milestone in the more than 8 years of work to fine-tune our methodology and working with nearly 300 investigative sites in 25 countries around the world."

*http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022264s000medr.pdf

About MedAvante

MedAvante is the premier global provider of centralized expert psychiatric rating and monitoring services to the pharmaceutical, biotechnology and medical device industries. Our flagship service, MedAvante's Remote Centralized Ratings™ are real-time assessments, either by telephone or videoconference, of subjects in global drug trials. Centralizing the assessors and blinding them to study protocols, results in a level of standardization, calibration and objectivity that is not achievable with a decentralized group of study raters participating from unconnected investigative sites. In addition to Centralized Ratings, the company provides Continuous Quality Control CQC, a monitoring service in which expert calibrated trainers review site-based study interviews via audio and video.  MedAvante's solutions help sponsors achieve increased drug effect and reduced trial failure rates, enabling them to bring better drugs to market faster. MedAvante operates facilities in Hamilton, NJ; Madison, WI; and Moscow, Russia.

(1)  Pandina, G. J., Lindenmayer, J. P. , Lull, J., Lim, P., Gopal, S.,  Herben, V., Kusumakar, V., Yuen, E., & Palumbo, J.  (2010). A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia.  Journal of Clinical Psychopharmacology, 30, 235 – 244.  doi: 10.1097/JCP.ob013e3181dd3103


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