Epilepsy

Epilepsy has a prevalence of ~0.6%,
affecting an estimated 1.9 million people in the United States

Lennox Gastaut Syndrome (LGS) accounts for 2-5% of childhood epilepsies

Overview

Epilepsy is a central nervous system disorder which causes seizures. A seizure is a sudden surge of electrical activity in the brain which can cause impaired or lost consciousness and/or a loss or increase in muscle tone depending on the type of seizure. The occurrence of two or more unprovoked seizures separated by at least 24 hours is considered epilepsy. Epilepsy can affect people of all ages, with onset occurring most frequently in childhood and older-adulthood. Epilepsies and epilepsy disorders range in severity; the impact the seizures have on individuals and their families can be very severe with concerns about having a seizure while swimming, driving, or in other potentially dangerous situations.

LGS is a severe form of epilepsy characterized by frequent and multiple seizure types. One of the seizure types patients with LGS experience are ‘drop attacks’: sudden, complete losses of posture involving a fall of either the head only or the whole body. About one- to two-thirds of LGS patients have drop attacks, which typically last less than 15 seconds. The majority of LGS patients (91%) have some mental retardation and ~22% require a feeding tube or have difficulty swallowing (dysphagia).

Current Treatment

Epilepsy is treated with antiepileptic drugs (AEDs). For about 60% of patients, seizures can be well controlled with AED treatment, but there are refractory seizure types and epilepsy syndromes in which the goal of complete seizure freedom cannot be achieved and the goal of treatment is to control the more severe, dangerous seizure types.

There are 6 AEDs approved for use in LGS. Few patients are able to achieve complete seizure freedom despite AED intervention, so the goal of pharmacotherapy in this refractory patient population is to control the more severe seizure types (drop seizures). This often requires a complicated regimen comprising multiple different medications taken multiple times per day.

Unmet Medical Needs

Because seizures are unpredictable in nature, it is important that AED-treatment be stringently maintained to reduce and/or prevent the risk of breakthrough episodes. There are 15 commonly used, FDA-approved antiepileptic drugs, none of which are available through non-oral delivery systems. A transdermal AED would offer the epilepsy patient population an alternative to their daily oral medications, thereby potentially reducing the caregiver burden and improving adherence to their prescribed dosing regimen. In LGS and other severe, refractory epilepsy syndromes and seizure types, the risk of nonadherence and caregiver burden are more pronounced and the benefit to these populations from a transdermal alternative would be considerable.