Greenwich Biosciences, a subsidiary of GW Pharmaceuticals, shared phase 3 data in poster presentations at the recent American Epilepsy Society Annual Meeting showing that it’s investigational cannabidiol agent Epidiolex is both efficacious and well tolerated. Of note, each pivotal phase 3 study achieved the primary endpoint demonstrating a statistically significant difference between Epidiolex and placebo in seizure frequency reduction during the 14-week treatment period. Additionally, in the 12-week maintenance period (excluding the initial dose escalation), the treatment effect increased for patients receiving Epidiolex and showed a greater level of statistical significance compared with placebo, according to the findings. Interestingly, in the LGS study, the drop seizure responder analysis showed a statistically significant separation between Epidiolex and placebo at the 50 percent seizure reduction threshold. In all trials, Epidiolex efficacy was established relatively early in treatment and was generally well tolerated.
As general interest in cannabidiol-based therapies continues to rise, Greenwich Pharmaceuticals CEO Justin Gover believes that one of the directives of the company will be to help physicians and the scientific community at large better understand this new modality. “Epidiolex is a pure cannabidiol—a quality controlled manufactured formulation,” said Mr. Gover in an interview. “What’s needed now is true medical education and a real proactive reaching out to physicians who are wanting information,” he said.
With the Phase 3 data, Mr. Gover believes that Epidiolex is proving to be a potentially viable agent in the landscape of epilepsy therapy. “Aside from excitement around the topic, this data is robust. This agent has met primary secondary endpoints and has shown very good tolerability.” Beyond the interest in the potential of cannabidiol, specifically, Mr. Gover said that the data warrants the interest of any first-in-class agent. “From a physician perspective, the idea of a new potential agent with broad seizure activity that is well tolerated that has shown that it produced a meaningful reduction in seizure activity in highly refractor types of patients who have failed to respond to treatments is significant,” he observed. “This represents a new mechanism and a new approach to epilepsy, and what one that’s welcomed.”Next Story