Abuse liability assessment


Abuse liability assessment refers to the testing of a neuroactive substance for its potential to become a drug of abuse. 

Any prescription medicine has the potential to be abused. However, drug products capable of producing rewarding psychoactive effects such as sedation, euphoria, hallucinations or mood changes, are considered to be at greater risk of being used recreationally. 

As a result, new drug applications (NDA) for medications that could affect the central nervous system (CNS) must include an assessment of their potential for abuse.

Assessment of abuse liability not only involves a consideration of a drug’s potential for addiction, but a broad range of other factors associated with its potential for misuse, abuse and diversion. These can include the drug’s therapeutic indication, availability and ease of synthesis, as well as the potential for negative outcomes resulting from abuse, such as overdose or toxicity. 

A comprehensive package of information is essential in guiding the decisions of pharmaceutical companies, government agencies, healthcare professionals, and ultimately, the patients who use the product.

Increasingly, abuse liability is incorporated early in development to allow for proper risk mitigation. Thus, planning for potential abuse liability should begin at the candidate selection stage to avoid unexpected surprises during early clinical trials.

Evotec uses a two-tiered, integrated approach for its abuse liability assessment programmes.

First, the compound undergoes pharmacological and pharmacokinetic characterisation.
Second, Evotec can then determine and perform the most suitable behavioural studies to unveil a compound’s abuse potential from different perspectives, including:

  • Drug discrimination to determine the compound’s similarity with known abused drugs
  • Self-administration to understand the compound’s reinforcing properties
  • Conditioned place preference as an additional approach to assess a drug’s rewarding or aversive effects
  • Physical dependence to analyse the compound’s potential to cause withdrawal symptoms

The scheme below can effectively illustrate this approach:

Evotec’s expertise in abuse liability assessment studies

  • GLP safety and behavioural assessment (including abuse liability assessment)
  • Consulting on abuse liability strategy including 8-factor analysis
  • Evaluation of chemical similarity to drugs of abuse
  • Broad range of behavioural studies including: drug discrimination; self-administration; withdrawal; locomotor activity 
  • Integration of behavioural assessment with DMPK assessment to establish PK/PD relationship

Areas of excellence

Evotec can deliver all the required studies as integrated development programmes addressing benefits such as:

  • Anticipate and address potential issues timely
  • Minimise development time
  • Maximise likelihood of success
  • Ensure effective team interaction and communication
  • Drive programme by the right experts through all its phases 

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