(Reuters) – GW Pharmaceuticals Plc said on Monday 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 United States 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 1 and 65.
The doses were able to reduce seizures by 47.5 percent and 48.6 percent, compared with a 26.5 percent 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 U.S. approval in the fourth quarter.
TSC is a rare genetic condition that causes tumors to grow in different organs and affects as many as 40,000 to 80,000 people in the United States. GW estimates over 90 percent of TSC patients have epilepsy, many of whom do not respond to existing treatments.
Reporting by Tamara Mathias in Bengaluru; Editing by…