Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017 Page 9
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37Contains Nonbinding Recommendations
• Pharmacodynamic studies showing ability of the drug to induce general behavioral
changes in animals and humans indicative of CNS activity
If assessment of data from these studies or subsequent studies leads to the conclusion that the
new drug has CNS activity, an abuse potential assessment will likely be required under
314.50(d)(5)(vii).
Question 2: For CNS-active new drugs, what is the next step for assessing abuse potential?
For new drugs determined to be CNS-active, the next step for sponsors should be to design and
conduct abuse-related animal behavioral studies, such as drug discrimination and self-
administration studies. Detailed descriptions and considerations in designing these abuse-related
animal behavioral studies are discussed in Section IV.D.
The results from these abuse-related animal behavioral studies are important factors for the third
key question:
Question 3: Should a human abuse potential (HAP) study be conducted?
A HAP study (also known as a human abuse liability (HAL) study) assesses abuse potential in
individuals with a history of recreational use of drugs of abuse. In determining whether a HAP
study should be conducted, it is important to assess whether there is evidence that the new drug
produces any of the following:
• Responses in animals in general behavioral studies that are similar to responses to known
drugs of abuse
• Generalization (similar effects) to a known drug of abuse in animal drug discrimination
studies
• Rewarding properties that support animal self-administration or conditioned place
preference
• A profile of abuse-related AEs (including euphoria-related AEs) in clinical studies in
healthy individuals (phase 1) and in individuals with the disease of study (phase 2/3)
These studies are discussed in detail in Sections IV and V. If evaluation of the data from these
animal and human studies identifies abuse-related signals, it is likely a HAP study will be
necessary to conduct. Detailed descriptions and considerations in designing a HAP study are
discussed in Section V.C.
If an evaluation of data from animal and human studies does not show evidence of abuse-related
signals, a HAP study is not likely to be recommended. However, the sponsor should discuss
available data with the Agency to confirm whether or not a HAP study should be conducted.
Once the data from all appropriate abuse-related studies in animals and humans are evaluated,
final decisions can be made regarding the fourth key question:
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