It is defined as a pattern of repeated seizures. Known causes include head injuries, brain tumors, lead poisoning, mal-development of the brain, genetic illness and infectious illnesses. However, in half of cases, no cause can be found. Oral medications (anticonvulsants, antiepileptic drugs) are the first line of treatment for epilepsy and, in most patients, control seizures.

Oral medications are not effective in 20% of epilepsy patients.

Patients who are resistant to conventional orally administered therapeutics are “refractory patients” and these patients are the core issue for clinicians treating epilepsy. In the United States, 28,000 new refractory epilepsy cases are detected each year.

Over the last 20 years, new anticonvulsant drugs have been discovered that offer fewer side effects than current medications. In addition, many refractory epilepsy patients have moved beyond taking a single drug to taking multiple anticonvulsant drugs, without successful treatment.

Non-compliance further decreases the successfulness of oral medications.

Successful treatment with anticonvulsants depends on achieving consistent levels of medication within the brain. Failure to meet medication-dosing regimens leads to an increase in seizures. On average, 30 – 40 percent of epileptic patients are known to be non-compliant with their drug regimen. The medical consequences of non-compliance are well known and documented. A recent study of 30,000 patients found a threefold increase in mortality as compared to drug compliant patients along with a higher incidence of emergency-room visits, hospitalizations and fractures. Further, non-compliance is a major cause of increased healthcare cost in the treatment of epilepsy.

Total Patients 1.0% or 3 million
Refractory Patients 1,000,000
Most Severe Refractory Patients 600,000
Refractory Epilepsy Treatment Market $2.5 billion
Antiepileptic Drug Market (World, 2008) $11.34 billion