Food and Drug Administration (FDA) Approval of GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences’ EPIDIOLEX® (cannabidiol) CV Marks First Drug Approval and Scheduling Decision Supported by Analgesic Solutions’ MADDERS® System
Drug Enforcement Agency (DEA) Places FDA-Approved Drug Containing CBD in Schedule V
WAYLAND, Mass., Oct. 22, 2018 /PRNewswire/ — Analgesic Solutions LLC is proud to announce Greenwich Bioscience’s EPIDIOLEX marks the first medication approval and scheduling decision supported by data from the Misuse, Abuse and Diversion Drug Event Reporting System (MADDERS®). EPIDIOLEX was approved by the FDA June 25, 20181. FDA approval and DEA rescheduling of EPIDIOLEX from Schedule I to Schedule V (which the DEA defines as having the lowest potential for abuse) ensure that this drug will soon be available by prescription to appropriate patients.
Dr. Ryan Lanier, Ph.D., Associate Director, Consulting at Analgesic Solutions commented, “We are focused on helping companies bring new and better medications to the market, and we are proud of the small role we played in what was a herculean effort on GW’s part to move this drug through the regulatory pathway to approval. This process is the example for future cannabis-derived medicines and the inclusion of our MADDERS system in the clinical development of EPIDIOLEX is a major accomplishment for us.”
ABOUT MADDERS® System
As of 2017, all investigational drug products with possible Central Nervous System (CNS) activity are required by the FDA to be comprehensively assessed for abuse potential2. Assessing abuse potential in humans includes identifying potentially abuse-related events in safety and efficacy clinical trials and reporting those events to FDA to assist in approval, labeling, and scheduling recommendations. MADDERS system is the only standardized system which prospectively and systematically assesses potentially abuse-related events in clinical trials.
ABOUT ANALGESIC SOLUTIONS
Analgesic Solutions, LLC., founded in 2006, is a privately held company that reduces the risks in clinical trials through consulting, innovative tools, data science, technology and training. 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 clinical trials, central statistical monitoring, and specialized training.
2 Food and Drug Administration Center for Drug Evaluation and Research (2017). Guidance for Industry: Assessment of Abuse Potential of Drugs (FDA Maryland).
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.