Epilepsy is a central nervous system (neurological) disorder in which brain activity becomes abnormal, causing seizures or periods of unusual behavior, sensations, and sometimes loss of awareness.
Approximately 50 million people currently live with epilepsy worldwide. Globally, an estimated 2.4 million people are diagnosed with epilepsy each year. In high-income countries, annual new cases are between 30 and 50 per 100 000 people in the general population. In low- and middle-income countries, this figure can be up to two times higher.
3 million people in the US annually, at an estimated annual cost of $17.6 billion in direct and indirect costs. 200,000 new cases of seizures are reported annually in the US, and approximately 10% of the American population will experience at least one seizure in their lifetime. Seizures dramatically affect the quality of life and daily activities. China has 6-7million people affected by epilepsy, incidence in children and elder adults (65 years old) are much higher, it is estimated pediatric epilepsy prevalence is 2.98-8.8%, about 10-15x of adults.
Commonly used AEDs are effective to various classes of epilepsy. There is a clear need in developing age appropriate dosage forms to treat epilepsy patients as well as to ease the titration schedule required for many of these drugs, therefore improve compliance and lower healthcare cost.
In addition, for many of the CNS conditions, including bipolar disorder, schizophrenia, epilepsy, a more patient compliant dosage form such as weekly, monthly injection, or controlled release formulation that enables once daily dosing and a much better peak to trough profile are strongly preferred.