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FDA Approves NDA Supported By MedAvante Central Ratings
Date:7/31/2012

HAMILTON, N.J., July 31, 2012 /PRNewswire/ -- MedAvante, Inc., the world's leading provider of centralized assessments in clinical trials of treatments for central nervous system (CNS) disorders, announced that MedAvante Central Ratings, used to assess the potential for psychiatric side effects in a non-psychiatric clinical program, was deemed an acceptable methodology for signal detection in a New Drug Application (NDA) approved recently by the U.S. Food and Drug Administration (FDA).

Cipher Pharmaceuticals announced FDA approval of Absorica™, a novel, patented brand formulation of the acne medication isotretinoin, for the treatment of severe recalcitrant nodular acne in late May.  In the course of the clinical program, MedAvante mental health experts conducted more than 8,000 remote, live psychometric assessments of patients at 50 investigative sites in the U.S. and Canada.

"The traditional methods of assessing psychiatric changes in a clinical trial have a tremendous amount of variability which can reduce signal detection," said Dr. Jason A. Gross, Vice President, Scientific Affairs at Cipher.  "The use of MedAvante's methodologies was a cornerstone of our clinical program and we are of the opinion that they increased the precision of the study results."   

"Cipher's use of our mental health assessment methodology demonstrates how MedAvante Central Ratings can benefit many types of clinical trials," said Paul M. Gilbert, co-founder and Chief Executive Officer of MedAvante.  "We have a proven capability, the need for which is endorsed by regulatory authorities as part of product development for certain pharmaceuticals."

"MedAvante can seamlessly integrate blinded independent mental health clinicians into a non-psychiatric study such as Cipher's, supporting them with responsive operational logistics and intelligent systems, without interfering in standard study procedures," said Gilbert.

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