Central nervous system (CNS) diseases encompass a broad range of conditions ranging from neurodegeneration and mood disorders to pain and addiction. These disorders have traditionally been separated into neurological and psychiatric diseases. Neurological disorders are physical diseases of the nervous system, while psychiatric disorders are abnormalities of thought, feeling, or behavior.
For most neurological and psychiatric disorders, pharmacological targets are located in the central nervous system. This presents an obstacle for drug development because it is difficult to deliver drugs across the blood-brain barrier and it is challenging to measure drug concentrations in the central nervous system.
Typical plasma sampling for pharmacokinetic (PK) analysis is usually insufficient for neurological/psychiatric drug development programs. Sophisticated modeling is usually required to allow analysis and interpretation of PK data for these drugs.
The endpoints measured during preclinical and clinical studies of neurological/psychiatric drugs are often necessarily complex. This requires careful planning and management in order to draw reliable conclusions about a drug’s efficacy.
Nuventra’s extensive experience in this field gives us the ability to properly advise on the many challenges associated with neurological/psychiatric drug development.
Nuventra’s Central Nervous System Experience
Nuventra can perform any of our wide range of services for drugs to treat Central Nervous System indications. Some of our recent project experience in this area includes:
- Clinical Development Plans
- Data Management
- Design and Execution of Phase I-III Studies
- Developing Regulatory Documents in Support of US and Global Product Registration
- Due Diligence
- PK/PD Monitoring and Analyses
- Regulatory Meetings
- Regulatory Writing and Submissions
Visit our services page to see our full range of services and to learn more about what our drug development consultants can offer your program.
Central Nervous System Indications
Nuventra has experience with a number of CNS indications, including:
- Abuse Deterrent Technology (for Opioid Drugs)
- Acute and Chronic pain
- Alzheimer’s Disease
- Essential Tremor
- Movement Disorders (including Tardive Dyskinesia)
- Parkinson’s Disease