GW’s Epidiolex on track for LGS filing mid-year

GW Pharma’s Epidiolex has impressed again in a late-stage trial involving patients with the rare form of epilepsy Lennox-Gastaut Syndrome (LGS), significantly reducing the number of drop seizures experienced.

Findings from the Phase III GWPCARE3 study, released by the American Academy of Neurology (AAN), showed that adding Epidiolex (cannabidiol or CBD) to patients’ current treatment significantly reduced the frequency of drop seizures at both the 10 mg/kg/day and 20mg/kg/day doses tested.

During the 14-week treatment period, patients taking both doses of Epidiolex saw a significantly greater median reduction in monthly drop seizures - 37 percent and 42 percent, respectively - compared with a 17 percent reduction for placebo.

New data from key secondary endpoints also showed that a significant number of patients receiving Epidiolex 10 mg/kg/day (36 percent) and Epidiolex 20 mg/kg/day (40 percent) experienced a 50 percent or greater reduction in monthly drop seizures compared with those taking placebo (15 percent).

In addition, significantly more patients/caregivers reported an improvement in overall condition with the 10mg/kg/day dose (66 percent) and the 20mg/kg/day dose (57 percent) compared to 44 percent for placebo, and the drug was found to be well tolerated in the trial.

"Lennox-Gastaut syndrome is one of the most challenging types of epilepsy to treat. Results from this large, placebo-controlled study demonstrate that Epidiolex provides clinically meaningful reductions in seizure frequency together with an acceptable safety and tolerability profile," noted study investigator Anup Patel, M.D., of Nationwide Children’s Hospital and The Ohio State University College of Medicine.

"I believe Epidiolex has the potential to change the treatment of LGS and I am excited at the future prospect of prescribing an appropriately standardised and tested pharmaceutical formulation of cannabidiol."

"This latest data from our Phase III program reinforces the potential of Epidiolex to become an important new medicine for patients who suffer from LGS and our planned NDA submission remains on track for the middle of this year," added Justin Gover, GW's chief executive.

The drug was awarded Orphan status for the LGS indication by European regulators back in March.