New data regarding the use of Epidyolex (Cannabiniol) in the treatment of the rare condition tuberous sclerosis complex (TSC) has pointed to the use of the product having a positive impact in seizure frequency for the patients included in the trial.
The findings of the study were presented recently at the annual meeting of the American Epilepsy Society.
TSC is a very rare condition affecting approximately 1 million people worldwide. The condition causes mostly benign tumours to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys and lungs. While TSC itself is not a type of epilepsy, it is a leading cause of genetic epilepsy and those with the condition experience seizures as result of TSC.
The study looked at 224 people in six countries between the ages of 1 and 65 and treated them with either 25mg of Epidyolex per day or 50mg of Epidyolex per day. 75 participants received 25mg and 73 were placed on 50mg per day for a 16-week period while the remaining 76 participants were placed on a placebo.
The results found that those on 25mg experienced seizure reduction of 49% while those on 50mg experienced seizure reduction of 50%. Seizures were reduced by 27% in the placebo group.
Adverse events (side effects) were common, occurring in over 90% of all patients in the trial. These included diarrhoea, decreased appetite and sleepiness. However, only 20 of the 224 patients discontinued the trial due to adverse events.
The results of this study indicate another potential group who could benefit from this drug, which received marketing approval in the EU in September for two rare forms of childhood epilepsy, Dravet Syndrome and Lennox Gastaut Syndrome.
Epidyolex has also been made available for NHS reimbursement in the UK for these conditions. No application for reimbursement has yet been made to the authorities in Ireland but this data adds to the case for access to the drug here in Ireland.
We will continue to follow up with Epidyolex’s manufacturers regarding their plans to make this medication available in Ireland for Dravet and Lennox Gastaut Syndrome and will update our website and social media channels as soon as we know more.
Further details on the study above can be found by visiting the Biospace website. (N.B; Epidyolex is marketed as EPIDIOLEX in the USA).