Drug Abuse Assessment Education Center
Assessing a drug or new molecular entity’s (NMEs) abuse potential is a global regulatory requirement for all CNS active pharmaceuticals and major metabolites.
The abuse assessment process is complex and different for each compound; the key is to consider and discuss this potential requirement early in development and to work closely with study design leaders to navigate the complex regulatory filing system.
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A data analysis strategy for nonclinical self-administration studies (Webinar Recording)
Assessments of a drug’s potential to be abused includes data from non-drug abuse related studies (such as the chemical properties of the drug) in vitro receptor-ligand binding, pharmacokinetics, general behavior (e.g. Irwin test, spontaneous activity tests) and adverse effects from clinical studies (e.g. hallucination, euphoria), in addition to specific abuse-related studies.
Drug abuse-related studies are conducted under GLP conditions and assess the reinforcing potential of a drug (self-administration), the potential of a drug to induce interoceptive stimulus (sensations) comparable to that of another drug (drug discrimination) and the potential of a drug to produce physical dependency (withdrawal effects upon dose cessation).
Related to this field of work are investigative studies that can provide early information about the potential abuse risk of a drug by characterizing specific behavioral effects such as behavioral sensitization and tolerance.
Finally, efficacy studies are used to assess a drug’s potential to treat a substance use disorder (SUD), to act as an abuse deterrent or to provide analgesia with an associated lower abuse risk.
If you're looking for more information about your compound and its potential for abuse, reach out.