GW Pharma boasts new positive data, readying for approval
The latest data from GW Pharma is about as conclusively positive as you can usually hope to get with a new drug, smashing performance against placebo on both primary and secondary endpoints.
The stage looks set for the first approval of a cannabis-derived product, barring any unexpected surprises. Uncertainty over how a drug made from a plant that is designated as a Schedule I by the DEA, which means that it is regarded as having no potential medical value, has never really left the background of the GW’s work.
However, an objective analysis of the benefits of GW’s cannabidiol-based Epidiolex medicine suggests that the FDA may take a different line to the DEA.
In the latest Phase 3 data release regarding the medicines impact on Lennox-Gastaut syndrome (LGS), a form of childhood-onset epilepsy, a 14-week trial involving 171 patients showed that those taking Epidiolex witnessed a median reduction in drop seizures of 44%, compared to 22% of those taking placebo.
In key secondary endpoints, the study also revealed that more patients taking Epidiolex also experience a 50% of greater reduction in drop seizures compared to placebo (44% against 22%). As well as this, total seizure frequency was reduced (41% compared with 14%).
Drop seizures are characterised by a brief loss of muscle tone that causes the neck muscles to relax and the head to drop, potentially resulting in a fall and serious injury.
“The publication of these positive results is an exciting milestone for the LGS community and we are encouraged that a new treatment option could soon be available,” said Christina SanInocencio, Executive Director of the Lennox-Gastaut Syndrome Foundation. “Additional treatment options are desperately needed for patients who continue to struggle with uncontrolled seizures and these results offer much needed hope to those living with this debilitating condition.”
GW Pharma has already applied for an NDA and has received a priority review designation was given for Epidiolex as a treatment for LGS and Dravet syndrome. A decision is expected by the FDA before 27 June.
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