SYS-CON MEDIA Authors: Gilad Parann-Nissany, Kevin Benedict, Unitiv Blog, Mark R. Hinkle, Glenn Rossman

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Certara Conducts Model-based Meta-analysis to Compare the Efficacy and Tolerability of Two Chronic Nonmalignant Pain Medications

Certara™, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, announced today that its model-based meta-analysis comparing tramadol with tapentadol for the treatment of chronic nonmalignant pain has been published in the journal Pain and Therapy. This study provides an indirect comparison of the efficacy and tolerability profiles of the two medications. The resulting peer-reviewed paper is now available online at http://link.springer.com/article/10.1007/s40122-014-0023-5.

“Our model-based meta-analysis demonstrated that the benefit-risk profiles of tramadol 300 mg once daily and tapentadol 100-250 mg twice daily were approximately equal,” said lead author and senior pharmacometrician at Certara, Francois Mercier.

Model-based meta-analyses are commonly used to study time dynamics of an endpoint. Usually these models take a non-linear form to fit longitudinal data, and to study the dose-response relationship, either at the group level or by combining aggregated data with individual level data.

For this study, data were analyzed from 45 Phase II and Phase III studies, representing a total of 81 treatment arms, and approximately 13,000 patients. After the initial selection of raw data from the literature, a critical data wrangling step was performed to transform heterogeneous and discordant information into clinically meaningful and comparable data.

Meta-analyses were used here to study pain intensity over time and across doses, as well as adverse event and drop-out frequency, amongst subjects experiencing chronic nonmalignant pain, who were being treated with tramadol or tapentadol. The most commonly reported adverse events were constipation, nausea, vomiting, dizziness, and drowsiness. Subjects stopped taking the medication either due to an adverse event or lack of drug efficacy.

This project was sponsored by Mundipharma Research.

About Certara

Certara is dedicated to improving human health by delivering a broad spectrum of software products and consulting services, spanning molecular discovery to clinical development, with special focus on supporting translational approaches to drug development. A leading provider of model-based drug development tools, Certara was formed by the acquisition and integration of industry leaders Tripos®, Simcyp™, and Pharsight® Corporation. Each Certara family brand focuses on a key phase within the drug discovery and development process; combined, they offer a unique set of scientific modeling, analysis, and simulation capabilities that can enable the cross-disciplinary approaches necessary for translational science initiatives. For more information, visit www.certara.com.

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