UK-based GW Pharmaceuticals has reported positive data from its Phase III clinical trial of Epidiolex (cannabidiol or CBD) to treat seizures associated with Lennox-Gastaut syndrome (LGS).
Epidiolex has been developed as a liquid formulation of pure plant-derived Cannabidiol (CBD) to treat various orphan pediatric epilepsy syndromes such as Dravet syndrome and Lennox-Gastaut syndrome.
The randomised, double-blind placebo-controlled Phase III trial enrolled 225 patients diagnosed with LGS aged between two and 55 years in its three study arms.
The patients were already undergoing one or more concomitant anti-epileptic drugs (AEDs) therapy and administered with Epidiolex.
The trial was primarily focused on comparing the efficacy of Epidiolex with placebo.
Results suggested that patients in both dose groups exhibited a greater percentage drop in LGS-induced seizures after being administered with Epidiolex, in comparison to placebo.
Additionally, Epidiolex was also generally well-tolerated throughout the study.
GW CEO Justin Gover said: “We are very pleased to report this second positive Phase III trial in seizures associated with Lennox-Gastaut Syndrome.
“This is the third positive Phase III trial for Epidiolex reported in 2016. All three trials provide GW with robust evidence to support the efficacy and safety of Epidiolex.
“This latest trial also shows that Epidiolex likely has an effective dose range, allowing for dose flexibility to address individual patient needs.
"These compelling results make us more determined than ever to make this important new medicine available to patients who suffer from these treatment-resistant, childhood-onset epilepsies.”
Epidiolex has also demonstrated a positive outcome in the first pivotal Phase III trial held last year for the treatment of LGS induced seizures, as well as another to treat seizures associated with Dravet syndrome.