Abuse potential assessment, clinical and regulatory strategy
- A development and regulatory strategy to address the FDA’s expectations regarding the thorough assessment of your drug’s abuse potential
- Due diligence on your drug’s relative abuse potential, probable scheduling and identification of factors that will likely affect scheduling
- Help preparing for key agency meetings (e.g. pre-IND, Type C, EoP2, pre-NDA)
- An abuse potential assessment report for your NDA submission (required by the FDA for all CNS-active drugs)
- A clinical development strategy to differentiate your product based on the unmet need of patients, benefits to the public health and pharmacoeconomic considerations
- Thorough preclinical and clinical abuse potential assessment strategies for regulatory submissions to the FDA, EMA, and other regulatory agencies
- Preclinical study design and due diligence in collaboration with David Heal and colleagues at DevelRx, experts in evaluating the abuse and dependence risks of new CNS-active drugs.
- Human Abuse Potential trial design and interpretation
- Assessment of clinical trial data related to abuse potential, including study design and interpretation
- Comprehensive abuse potential assessment reports with scheduling recommendations (including DEA 8-factor analysis)
- Target Product Profile development and clinical development strategies to address key differentiating product attributes
- Prepare sponsors for meetings with regulators and serve as outside experts in regulatory meetings
- Behavioral and Clinical Pharmacology
- Clinical Drug Development
- Regulatory and Health Policy
- Integrated Strategic Communications
Value to our clients
PinneyAssociates includes internationally respected leaders in the development of CNS-active drugs with unparalleled expertise in the assessment of abuse potential and the development of clinical and regulatory strategies to support the differentiation of novel products. During the past 40 years, our experts have served the National Institute on Drug Abuse, College on Problems of Drug Dependence, the FDA, and pharmaceutical companies in the development of methods, as well as the design, conduct, and interpretation of abuse potential assessment studies.
Our comprehensive abuse potential assessments of CNS-active drugs have helped our clients achieve appropriate scheduling under the U.S. Controlled Substances Act and international drug control conventions. Clients rely on our assessments to inform their drug development programs.