The company plans to file for a US approval in the fourth quarter
GW Pharmaceuticals said its drug Epidiolex was successful in treating seizures in patients with a rare form of childhood epilepsy called tuberous sclerosis complex during a late-stage trial. In June, the drug became the first cannabis-based medicine to be approved in the US after regulators permitted the treatment for two other forms of childhood epilepsy.
The trial tested two doses of the drug against a placebo in treatment-resistant tuberous sclerosis complex (TSC) patients aged between one and 65. The doses were able to reduce seizures by 47.5 per cent and 48.6 per cent, compared with a 26.5 per cent reduction in patients taking a placebo, the company said.
It expects to focus on the lower 25 mg/kg per day dose as it was associated with fewer side effects. The company plans to file for a US approval in the fourth quarter. TSC is a rare genetic condition that causes tumours to grow in different organs and affects as many as 40,000 to 80,000 people in the US. GW estimates over 90 per cent of TSC patients have epilepsy, many of whom do not respond to existing treatments.