Press Release (ePRNews.com) - TORONTO - Jun 18, 2018 - In a live session on Thursday, June 28, 2018 at 1pm EDT, featured speakers from PinneyAssociates Jack Henningfield, Ph.D., Vice President of Research, Health Policy and Abuse Liability and Reginald Fant, Ph.D., Director of Clinical Pharmacology and Abuse Potential Assessment, will focus on the role of an abuse potential assessment (also referred to as the Controlled Substances Act 8-factor analysis) in the development of CNS-active drugs and related interactions with FDA and DEA.
- Definitions and studies for assessment of abuse potential, from nonclinical to clinical
- Practical application of FDA guidance on Assessment of Abuse Potential of Drugs
- Optimal timelines for abuse potential of CNS-active drugs
- Regulatory timelines and abuse potential assessment
- Examples of drug and dietary supplement categories that may trigger an abuse potential assessment
Developers of drugs with central nervous system (CNS) activity rightly focus on physical safety and efficacy first, particularly in the case of products intended for rare disorders or diagnoses often unresponsive to existing therapeutic options. These products may have little if any apparent CNS mediated effects but crossing the blood-brain barrier is sufficient to trigger the FDA requirement for an abuse potential assessment.
It is widely understood that drugs under development for the treatment of CNS disorders, including pain, will require abuse potential assessment, but many substances that are not intended for treatment of CNS disorders may also require some level of assessment. Examples of categories that might trigger an abuse potential assessment include certain dietary supplements, cannabinoids, atypical antipsychotics, antidepressants, antiepileptics, novel analgesics and other drugs that primarily act peripherally, and even chemotherapies, that enter the brain and interact with receptors that are known to modulate abuse-related effects.
To avoid delays and unexpected costs late in development, drug development timelines need to take into consideration the 2017 FDA Guidance on Assessment of Abuse Potential of Drugs, which indicates that all CNS-active drugs will need some level of abuse potential assessment. While an assessment on the level that would be expected for an analog of an opioid, stimulant, or sedative would not necessarily be required for every drug candidate, at least some level of assessment would be expected to characterize the drug’s abuse potential as part of the safety evaluation of the substance. Nonclinical safety assessments and human data from early trials can be useful to collect early on. This would also allow time to meet with regulators for an early opinion as to the range of studies needed to properly assess abuse potential rather than waiting until the middle or end of Phase III studies. These abuse potential assessments may also provide early indication of the potential need for risk management programs to monitor and/or reduce abuse.
For more information about this complimentary event, visit: Crossing the Blood-Brain Barrier? FDA Requires an Abuse Potential Assessment.
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