FDA Approves NDA Supported By MedAvante Central Ratings
Jul 31, 2012
(Hamilton, NJ) 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.
About MedAvante, Inc.
MedAvante is the leading global provider of centralized expert psychiatric and neurocognition rating and monitoring services to the pharmaceutical, biotechnology and medical device industries. MedAvante solutions help sponsors achieve enhanced assay sensitivity for increased drug effect and reduced trial failure rates, enabling them to bring better drugs to market faster. With headquarters in Hamilton NJ and operations hubs in Moscow and Munich, MedAvante delivers central trial services in more than 20 countries worldwide from within each country. For more information, please visit www.medavante.com.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (TSX: DND; OTC: CPHMF) is a growing specialty pharmaceutical company that commercializes novel formulations of successful, currently marketed molecules. Cipher’s strategy is to in-license clearly differentiated products, advance them through the clinical development and regulatory approval stages, and out-license to international marketing partners. The Company’s first product is a fenofibrate formulation marketed in the United States as Lipofen®. Cipher’s second product, an extended-release tramadol, is marketed in the United States as ConZip™ and is marketed in Canada as Durela™. Cipher’s third product, a novel formulation of the acne treatment isotretinoin, was recently approved by the FDA and is expected to be launched in Q4 2012 as Absorica™. The product is also currently being reviewed by Health Canada. For more information, please visit www.cipherpharma.com.