GW Pharmaceuticals plc GWPH said Monday that the results of the company’s positive Phase 3 clinical trial of Epidiolex oral solution in seizures related to tuberous sclerosis complex were published in JAMA Neurology.
Epidiolex is the first FDA-authorized CBD medicine for treating children with severe forms of epilepsy. The medicine was first approved for treatments of seizures connected to Lennox-Gastaut syndrome and Dravet syndrome.
In July, the FDA also approved Epidiolex for managing seizures related to tuberous sclerosis complex.
Tuberous sclerosis complex is a genetic condition that causes the growth of tumors, usually benign ones, in vital organs, further causing genetic epilepsy.
Around 1 million people in the world suffer from the condition, which causes various types of seizures.
The results of the study JAMA Neurology published show that patients receiving Epidiolex as a treatment had considerably less TCS-associated seizures (48.6%) versus placebo (26.5%). This trial was the basis for the July 2020 FDA approval of Epidiolex for TSC-related seizures.
“People living with TSC may experience focal seizures and spasms as infants and continue to suffer from seizures throughout their lifetime,” Elizabeth Thiele, M.D., Ph.D. said in a statement.
Thiele is the director of pediatric epilepsy and director of The Carol and James Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital, a professor of neurology at Harvard Medical School, Boston and lead investigator of the trial . “This study demonstrated that for patients with TSC and a high baseline burden of treatment-resistant, primarily focal, seizures, Epidiolex significantly reduced the frequency of seizures compared with placebo.”
The safety profile in this study was aligned with observations from earlier studies of Epidiolex, GW Pharma said.
“The publication of these results in JAMA Neurology reinforces the importance of Epidiolex as a new treatment option for people experiencing treatment-resistant seizures associated with TSC,” CEO Justin Gover said in a statement.
“We hope that the data will help clinicians to better understand the potential of Epidiolex to reduce focal and generalized seizure frequency in their patients with this condition.”
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