Determining if a HAP or ADF Assessment is Needed
Investigating the Abuse Potential of your CNS-Active Therapeutic
The FDA Guidance, Assessment of Abuse Potential of Drugs, states:
Drug products with abuse potential generally contain drug substances that have central nervous system (CNS) activity and produce euphoria (or other changes in mood), hallucinations, and effects consistent with CNS depressants or stimulants. Thus, if a drug substance is CNS-active, the new drug product containing that drug substance will likely need to undergo a thorough assessment of its abuse potential…
The results of a human abuse potential (HAP) trial can indicate that your product will need an abuse-deterrent formulation (ADF), or specific labelling. Altasciences’ scientific, regulatory, and clinical experts will work with you to design a roadmap for your HAP evaluation program.
HAP trials are procedurally intense, requiring high levels of skill and experience, secure clinical facilities with the necessary licenses, and pharmacy capabilities and expertise to ensure appropriate handling and storage of the drug products.
For a more in-depth look at the requirements and implications of HAP trials for your drug development program, consult The Altascientist — Assessing Human Abuse Potential to Limit the Misuse and Abuse of Prescription Drugs.
Speak with an expert today for more information or to review your specific program requirements.
Related Resources:
Webinar: To Control or be Controlled – Navigating the Abuse Potential Evaluation of CNS-Active Drugs for EU and US Submissions
Scientific Poster: Identifying Appropriate Outcome Measures and Methodology to Evaluate the Abuse, Misuse, Dependence, and Impairing Effects of CNS-Active Drugs in Healthy Volunteer and Patient Trials
Webpage: Human Abuse Potential
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