We offer unrivalled abuse potential experience and expertise
Our experts can help guide you in determining if your product requires abuse potential assessment, and if so, how to strategically plan for studies that will meet your development and regulatory requirements.
We were the first CRO site to perform abuse potential studies under GCP and have conducted more abuse potential evaluations for new chemical entities and abuse deterrent formulations than anyone else.
Let our experts assist you
Our in-house team of PhD pharmacologists, neuroscientists and neuropsychologists have published and presented extensively in this area, and can help you with any aspect of abuse potential, from study design and implementation to regulatory reporting. With our extensive background in assessing abuse deterrent products, we can provide you with the best strategy for developing and executing robust programs to support labeling claims.
We offer reliable assessments and data capture
Abuse potential studies include multiple subjective and objective assessments to evaluate drug effects. Furthermore, training of subjects on these measures is critical to ensure study integrity and consistency. At the heart of our cognitive assessment service is a 21 CFR Part 11 compliant and validated computerized system, which implements our purpose-built questionnaires, behavioral measures and neurocognitive batteries. Our standardized and customized subject training programs ensure comprehension and consistency for our studies.
Our many services include:
- Abuse potential programs for new molecular entities in a range of compound classes (opioids, stimulants, ketamine, cannabinoids, benzodiazepines, hypnotics).
- Programs for abuse deterrent formulations.
- Proof-of-concept studies in substance abuse pharmacotherapy (using our methadone maintained and cocaine dependent volunteer populations).
- “Focus group” tampering studies.
- Generating regulatory strategies and assisting regulatory communications.
- Participating at regulatory meetings, including Advisory Committee and Advisory Board meetings.
- Preparing regulatory submissions (NDA, MAA, NDS), 8-Factor Analyses, briefing documents and response packages.
- Creating post-marketing surveillance strategies.
- Managing adverse event collection, coding and reporting.
- Conducting assessments of in vitro and in vivo tamper resistance.
We also offer a little advice when you need it
We help you make sure your abuse potential programs are strategically sound and compliant with regulations.
We will help you develop your abuse deterrent programs to support important labeling claims.
We can complete an 8-Factor analysis of your data to support your drug scheduling proposal at the time of NDA filing.
Early Phase Abuse Potential
Refers to the potential of a drug to be used for its psychoactive effects. Drugs with abuse potential often produce psychic and/or physical dependence.
Drugs requiring evaluation of abuse potential:
New chemical entities that:
- Affect the central nervous system
- Are chemically or pharmacologically similar to known drugs of abuse
- Produce psychoactive effects (e.g., sedation, euphoria, mood changes)
Marketed products that:
- Present an unexpected adverse event profile related to abuse potential
- Are being re-evaluated for a new route of administration that could affect abuse potential
- Abuse-deterrent formulations – new formulations designed with a possible claim of abuse-deterrent qualities
Components of abuse potential evaluation:
- Preclinical models In vitro testing (abuse deterrent formulations)
- Human Abuse Potential (HAP) study
- Withdrawal studies
- Adverse event assessments
- 8-Factor analyses
INC Research, a global leader in abuse potential evaluation:
- HAP studies
- Study design in accordance with FDA and Health Canada guidance
- Selection of appropriate comparators
- Recruitment of non-dependent drug users
- Pharmacodynamics training and assessment
- Pharmacy coordination of scheduled drug imports
- Human Abuse Potential Studies: Full clinical conduct and data analysis (Clinical Study Report)
- Unique HAP study considerations (e.g., qualification of subjects)
- 8-Factor Analyses for your NDA submission
- White paper and manuscript development
- Abuse potential in methadone-maintained subjects