Analgesic Solutions Presents Data on the use of MADDERS® to Assess Potentially Abuse-Related Events in Clinical Trials at the 79th Annual Scientific Meeting of The College on Problems of Drug Dependence
Analgesic Solutions is participating in the College on Problems of Drug Dependence (CPDD) Annual Scientific Meeting in Montreal, June 17-22, 2017.
Nathaniel Katz, MD, MS, Analgesic Solutions’ Founder, President and CEO, participated in the CPDD Workshop III: ASSESSMENT OF ABUSE POTENTIAL IN CLINICAL TRIALS IN THE CONTEXT OF THE FINALIZED FDA GUIDANCE, on Sunday, June 18. Dr. Katz discussed the development and feasibility of MADDERS® (Misuse, Abuse, and Diversion Drug Event Reporting System) during the collaborative workshop facilitated by Jack Henningfield, PhD, from Pinney Associates, and included members of the FDA’s Controlled Substance Staff, and Shannon M. Smith, PhD, from the University of Rochester School of Medicine and Dentistry.
“MADDERS is a unique and innovative methodology for systematically identifying, evaluating, and classifying potentially abuse-related events in clinical trials, and represents the culmination of years of development based upon ACTTION (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks) recommendations, feasibility testing, and iterative modification” said Dr. Katz. “MADDERS is the first system of its kind to be successfully implemented in multiple late-phase clinical trials testing CNS-active drugs from different pharmacological classes.”
Analgesic Solutions will also present two posters reporting MADDERS data collected from Phase III clinical trials sponsored by GW Research, Ltd, on Wednesday, June 21 from 8am-10am.
“Evaluation of Potentially Abuse-Related Events in Phase III Clinical Trials of Cannabidiol (Epidiolex®) using the MADDERS® Prospective System” – Poster 36
Authors: Ryan Lanier, Imrana Kazam, Harrison Elder, Roi Treister, Maitreyee Mohanty, Reni Kunkel, Tilden Etges, Nathaniel Katz; Analgesic Solutions, Natick, MA; GW Pharmaceuticals, plc, Cambridge, UK
“Evaluation of Potentially Abuse-Related Events in Phase III Clinical Trials of a Delta-9 Tetrahydrocannabinol and Cannabidiol (Sativex®) Oromucosal Spray” – Poster 37
Authors: Harrison Elder, Ryan Lanier, Imrana Kazam, Roi Treister, Maitreyee Mohanty, Matthew Hersch, Tilden Etges, Nathaniel Katz; Analgesic Solutions, Natick, MA; GW Pharmaceuticals plc, Cambridge, UK
Nathaniel Katz, MD, MS, will conclude Analgesic Solutions’ presentations at CPDD on Thursday, June 22 at 5pm with a 15-minute oral communication discussing the Development, feasibility, and implementation of the misuse, abuse, and diversion drug event reporting system (MADDERS®) for classifying misuse and abuse-related events in clinical trials.
More information about CPDD and the 79th Annual Scientific Meeting of CPDD can be found at: http://cpdd.org/
Analgesic Solutions developed MADDERS® in collaboration with the FDA-ACTTION initiative, and it is the first standardized system for classifying and quantifying abuse-related events in clinical trials.1,2 As of the second quarter of 2017, MADDERS has been successfully implemented in at least 9 multicenter Phase III clinical trials and 1 Phase IV post-marketing trial involving analgesic and non-analgesic (e.g., epilepsy) CNS-active medications.
ABOUT ANALGESIC SOLUTIONS
Analgesic Solutions, LLC., founded in 2006, is a privately held company that reduces the risks in pain clinical trials through consulting, innovative tools and monitoring. We are a hands-on team of experts who consult on, and conduct clinical trials in the process of bringing pain treatments to market. With hundreds of projects completed and ongoing collaborations with regulatory authorities, Analgesic Solutions is the premier choice for mitigating risk associated with measurement error in pain trials. Clients come to us when looking to develop and commercialize better treatments for pain. Our team, with Nathaniel Katz M.D., M.S., serving as our foremost expert, helps our clients bring their pain solutions to commercial reality.
- Treister R, Trudeau JJ, Van Inwegen R, et al. Development and feasibility of the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS®). Am J Addict. 2016;25(8):641-651.
- Smith SM, Dart RC, Katz NP, et al. Analgesic, Anesthetic, and Addiction Clinical Trials, Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership. Classification and definition of misuse, abuse, and related events in clinical trials: ACTTION systematic review and recommendations. Pain 2013; 154: 2287-96.
Analgesic Solutions, LLC, founded in 2006, is a privately held company focused on increasing assay sensitivity in the conduct of pain clinical trials through consulting, innovative tools and technology, and training. Our team, with Nathaniel Katz M.D., M.S., serving as our foremost expert, helps clients develop and commercialize better treatments for pain. With hundreds of projects completed and ongoing collaborations with regulatory authorities, Analgesic Solutions is the expert at identifying and mitigating the random and systematic errors that lead to negative clinical trials.