Assessment of abuse potential of compounds in development is one of the most complex regulatory requirements and constitutes a critical exercise for sponsors and regulators. The strategy for the assessment of abuse potential cannot be customized and requires individual evaluation of the compound, its target indication and the entirety of the nonclinical and clinical safety database. In July 2016, the United States Congress passed the Comprehensive Addiction and Recovery Act (CARA) bill to address prescription opioid abuse and overdoses that have killed more than 165,000 people between 1999 and 20141.
Given this increased spotlight and focus on preventing opioid abuse and deaths in the US and abroad, it has become more critical than ever to better understand the abuse liability potential of a drug as early as possible in the development process. As part of the overall assessment of drug safety for a New Drug Application (NDA) in the United States or a Market Authorization Application (MAA) outside the United States, drug abuse potential testing is required – regardless of indication – on any drug that is active in the brain. This encompasses all properties of the drug (e.g., chemical, pharmacological, pharmacokinetic, clinical safety, etc.).
In the first of a two-part blog, we share important early considerations for abuse liability testing to help drug developers test the abuse potential of their molecule and better understand their path to viability in this changing landscape.
Recognize the value of early work
Abuse liability testing is a complex process that can significantly impact the timeline of drug development. An early understanding of a molecule’s potential for abuse helps sponsors develop a comprehensive assessment plan and more quickly understand required adjustments that will need to be made to their respective timeline.
Early nonclinical screening helps identify key behavioral and physiological effects, looking at characteristics like social interaction, motor coordination, spontaneous locomotor activity, bizarre/stereotypical behavior or food consumption, which are commonly measured in known drugs of abuse. These screening tests give sponsors more information on a compound’s likelihood to require abuse liability testing, which can assist in planning and budgeting for their drug development program.
Devise an end-to-end strategy
From IND to NDA filing/review and post-marketing, it is crucial for sponsors to have an overall strategy for abuse liability testing. Each stage of testing should inform future development, stressing the need for an overall abuse liability testing plan that continually integrates results and adjusts the strategy as needed.
In our next blog, we’ll focus on important regulatory and market access considerations for abuse liability testing. Read the article here.
We help sponsors at every stage of abuse liability testing – from consultancy to running nonclinical and clinical studies along with support in market access and post-marketing. Learn more about how our drug abuse liability expertise and solutions can help advance your molecule.
1 CDC. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2016. Available at http://wonder.cdc.gov.