Cipher Pharmaceuticals Using MedAvante Centralized Ratings in Phase 3 Study
Cipher recently announced the completion of the patient enrollment phase of their clinical study, in which every patient is interviewed by a qualified MedAvante mental health expert at every visit of the study. MedAvante centralized raters are monitoring each patient's well-being to determine if any changes in mental status are detected while on medication.
The Cipher study is the first time MedAvante Centralized Ratings are being used to assess the safety and potential for psychiatric side effects of a non-psychiatric drug being studied in an ambulatory setting. Regulatory authorities have been requesting that companies evaluate the propensity of a non-psychiatric treatment to affect a patient's well-being as part of product development for certain pharmaceuticals.
"Clinical studies require specialized and sophisticated methodologies that are highly accurate and reproducible, and at the same time capable of assuring patient safety," said Dr. Jason A. Gross, Vice President of Scientific Affairs at Cipher. "We examined other methodologies of evaluating psychiatric events, including automated self-report systems," he said. "However, we found that only the MedAvante Centralized Ratings were able to provide the critical attributes of consistency and accuracy that the FDA and Cipher required."
"Our work with Cipher is evidence that centralized ratings can be beneficial to many types of clinical testing," said Paul M. Gilbert, Chief Executive Officer of MedAvante. "Centralized assessments in other therapeutic areas, including oncology, imaging and cardiovascular, are used to reduce bias and minimize variability and have been described affirmatively in regulatory guidance documents. We believe we achieve the same benefits with centralized psychiatric assessments," he said.
The Cipher study has required MedAvante centralized raters to conduct over 8,100 remote, live assessments of patients at 50 sites in the U.S. and Canada, and to report timely results to the sites. "MedAvante's role in the Cipher study demonstrates our ability to seamlessly integrate centralized raters into most non-psychiatric studies, by providing responsive operational logistics and without interfering in standard study procedures earning the acceptance of the dermatologists in the study," said Gilbert.
MedAvante's centralized raters are mental health professionals with deep clinical and rating scale expertise, carefully selected through an intensive qualification process, and continuously trained and calibrated.
About MedAvante, Inc.
MedAvante is the premier global provider of centralized expert psychiatric rating and monitoring services to the pharmaceutical, biotechnology and medical device industries. Its flagship service, Remote Centralized Ratings, provides 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 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. For more information, please visit www.medavante.com.
About Cipher Pharmaceuticals, Inc.
Cipher Pharmaceuticals is a commercial-stage drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies. Cipher's strategy is to in-license products that incorporate proven drug delivery technologies and advance them through the clinical development and regulatory approval stages, after which the products are out-licensed to international partners. Because Cipher's products are based on proven technology platforms applied to currently marketed drugs, they are expected to have lower approval risk, shorter development timelines and significantly lower development costs. The Company's lead compound is being marketed in the United States by Kowa Pharmaceuticals America under the label Lipofen®. Cipher's second product, an extended-release version of the pain reliever tramadol, received FDA approval in May 2010 and the Company's third product, a novel formulation of the acne treatment isotretinoin, is in its final Phase III safety study. Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit www.cipherpharma.com.
SOURCE MedAvante, Inc.