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The 8-Factor Analysis
The 8-factor analysis
How an Integrated Compelling 8-Factor Analysis Supported Appropriate Scheduling and Risk Management for a CNS Drug
Scheduling of a drug regulated under the Controlled Substances Act can be an important differentiator that impacts prescribing, utilization and manufacturing requirements. Scheduling also communicates a certain level of risk of dependence. The Controlled Substances Act requires an 8-Factor analysis for all scheduling decisions by the Drug Enforcement Administration. More recently, the Food and Drug Administration (FDA) draft guidance on abuse potential states that the New Drug Application for all CNS drugs must include “an assessment of studies and other information related to the potential abuse of a drug and include a proposal for scheduling.”
A medium-sized pharmaceutical company was preparing a NDA submission for a CNS-acting anesthetic. Prior to full data analysis, preliminary risk assessment suggested that the drug had high abuse liability and would be assigned commensurately restrictive scheduling placement. The client asked Pinney Associates to develop an 8-Factor Analysis synthesizing all relevant data and proposing an appropriate schedule to submit as part of the NDA.
Pinney Associates pharmacologists developed an 8-Factor Analysis by integrating the most current scientific knowledge relevant to abuse potential to establish the basis for appropriate scheduling of the drug. Our experts assessed and synthesized sources including preclinical and clinical studies, epidemiologic data, and the peer-reviewed literature. PA biostatisticians conducted targeted analyses of national datasets to include in the document. The goal was to provide an authoritative and scientifically credible report responsive to FDA and Drug Enforcement Administration (DEA) expectations.
The final 8-Factor Analysis submitted to the FDA’s Controlled Substances Staff and the DEA presented a coherent examination of the science relevant to scheduling of the drug. The agencies used the analysis to assist them in their scheduling decision and ultimately placed the drug in a less restrictive schedule than originally discussed based on an intense review of the science.