Drug Resistant Epilepsy
Refractory Epilepsy or Drug Resistant Epilepsy typically refers to Epilepsy wherein a person has failed to become seizure free with adequate trails of two seizure medications. About 50 million people worldwide are affected by Epilepsy (Sander, 2003). Epilepsy is due to multiple factors including Sodium, Potassium, GABA and NMDA. Modulating one or more of these receptors is required to maximally control epilepsy. It is believed that mono-therapy is adequate in up to 25 percent of patients.
Long Term Implications
The onset of epileptic seizures can be life threatening, including long-term implications (Lutz, 2004) such as mental health problems, cognitive deficits, and morphological changes (Swann, 2004, Avoli et al., 2005). The onset of epilepsy also greatly affects lifestyle as sufferers live in fear of consequential injury or the inability to perform daily tasks (Fisher et al., 2000).
Help from Phytocannabinoids
Several researchers have suggested that cannabis-based medicines may have the potential to treat hyper excitability in the central nervous system (Wingerchuk 2004, Alger, 2006). Consroe et al. in 1975 described the case of a young man for whom the standard treatment of Phenobarbital and phenytoin did not control his seizures. When the young man smoked cannabis he had no seizures. They concluded that cannabis might have anticonvulsant effects on human epilepsy.
In 1990 a study by Ng involving a population of 308 epileptic patients showed that the use of cannabis reduced seizures. However, the study was later criticized in a report in the Institute of Medicine (1999) that claimed health status prior to hospital admissions might have been a factor that influenced their drug use rather than the other way around.
Help from CBD
In 1980 Cunha et al., reported that patients that were administered 200-300 mg of cannabidiol in combination with regular medication, showed improvement over those that received a placebo. Mild sedation was reported as an unwanted side effect. In 1986 Ames reported a study in which 12 epileptic patients were given 200-300 mg of cannabidiol per day in combination with standard antiepileptic drugs with no significant improvement in seizure frequency. In 1990 Trembly et al reported that 900-1200 mg of cannabinidiol a day for 10 months markedly reduced the frequency of seizures in the single patient that they tested.
Help from THC
In addition to reports that suggest that CBD may be beneficial, a report by Davis and Ramsey shows that use of tetrahydrocannabinol (THC) may also help reduce seizures.
IGC has applied for a U.S patent based on a novel therapy using cannabinoid extracts. The therapy is administered, using a variety of delivery technologies, for indications in both human medical refractory epilepsy and seizures in other mammals such as dogs and cats. We expect to conduct metabolic profiling and apply to the FDA for trials.