FDA Guidance on Assessment of Drugs Abuse Potential
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FDA Guidance on Assessment of Drugs Abuse Potential
The abuse potential of a drug is a vital consideration in the development of a new drug. Physicians and healthcare providers need to know if the new drug is expected to be abused after approval and marketing to assure the protection of public health. Assessing drug abuse potential also provides the basis for controlling and regulatory actions related to drug control.
As a component of the safety evaluation of the new drug, FDA has recently finalized the guidance to aid investigational drug sponsors in assessing whether their new drug has abuse potential. According to this guidance, if the drug substance is CNS active and produce adverse effects such as hallucinations, the drug is likely to undergo detailed assessment of its abuse potential and is subjected to control under the Controlled Substances Act (CSA).
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Overview of the Requirements
The guidance covers drug products that contain CNS-active new molecular entities (NMEs) along with those products that contain CNS-active substances that are already regulated under the CSA. The key areas addressed in this guidance include:
- Chief decision points in assessing abuse potential including answers to the following questions:
- Is the new drug active within the CNS?
- What is the next step for evaluating abuse potential for CNS-active new drugs?
- Should a human abuse potential study be conducted?
- Preparing the NDA submission.
- NDA review and product labeling related to abuse potential.
- Abuse-related data from chemistry and nonclinical studies including pharmacological studies, pharmacokinetic data, and general animal behavioral effects.
- Abuse-related data from clinical studies including abuse-related adverse events from human studies, human abuse potential studies, clinical studies that evaluate cognition and performance, and clinical evaluation of physical dependence studies.
The guidance also offer recommendations on the use of post-marketing and illicit drug abuse data to ensure adherence to the FDA regulatory requirements.
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