Neurological disorders, including Alzheimer’s, Parkinson’s, Multiple Sclerosis, stroke, epilepsy, chronic pain and migraine are generally chronic conditions associated with high disease burden due to significant morbidity and disability. Generally, the therapeutic objectives are to deliver safe, effective and well tolerated therapies for long-term use, which enhance the quality of life of patients or intervene in the underlying disease process.
Many of the current therapies utilized to treat neurological disorders fail to reach their optimal potential in many patients. Inappropriate timing and variations in drug absorption within and across patients can result in suboptimal therapeutic effects or frequent and intolerable side-effects. These undesired outcomes can result in discontinuation of therapy, suboptimal therapeutic benefits or produce side-effects, which adversely impact the quality of life of the patient. As a result, the most obvious unmet need for the treatment of neurological disorders is to overcome the suboptimal therapeutic performance of current treatments.
Differentiated products with the following advantages:
Targeted profiles
Improved predictability and reduced variability in intra- & inter-subject plasma level
Enhanced safety profiles by the absence of high plasma peak levels
Improved patient compliance
Minimized food effect
Development and Regulatory Strategy:
Clinical benefit based on good PK/PD correlation
Proven surrogate endpoints directly related to efficacy
505(b)(2) NDA submissions in US accelerate data generation & approvals
Significant risk reduction in EU and Japan from US studies
