Prosecutors Challenged By Epidiolex Trial

GW Pharmaceuticals' cannabis growing facility.

Photo credit: GW Pharmaceuticals
By: Cecil King   

Prosecutors Challenged By Epidiolex Trial

Twelve Missouri prosecutors think “marijuana is a destructive drug, with no proven benefits (medical or otherwise).” However, British biotech company GW Pharmaceuticals has found marijuana has many medical benefits.

On Sept. 28, 2016 GW Pharmaceuticals (GW) announced positive results on its latest Phase 3 clinical trial for its cannabis-based drug Epidiolex.

In their motion to intervene in the New Approach Missouri (NAM) VS. Jason Kander lawsuit, Missouri prosecutors were trying to block Missouri citizens from voting on a medical marijuana initiative.

It was painfully clear to many cannabis activists not one of the twelve prosecutors had a medical degree to support their medical claims against marijuana. Missourians would rather consult with their doctor about medical treatment options and not give up their medical rights to self-proclaimed “experts”.

The Missouri Cole County circuit court entered a judgment against NAM’s initiative and the prosecutors’ motion was not heard. At least the intervening motion allowed Missourians a chance to know what their elected county prosecutors think of their right to vote on a personal medical issue.

Meanwhile, GW continues to provide scientific evidence through clinical trials their Epidiolex drug can reduce epileptic seizures by 42% for a difficult to treat childhood epilepsy called Lennox-Gastaut Syndrome or LGS.

“Today brings great news for the Lennox-Gastaut Syndrome community,” said Christina SanInocencio, Executive Director of the Lennox-Gastaut Syndrome Foundation. “The announcement of a second set of positive results with Epidiolex is exciting as they offer much-needed hope for patients and their families living with this debilitating condition where new treatment options are desperately needed.”

GW’s Epidiolex is having a great year in 2016. Following the success of the first Dravet Syndrome Phase 3 trial in March, GW met with the U.S. Food and Drug Administration (FDA) to discuss filing a New Drug Application (NDA) for its cannabis-based medicine. GW believes it can submit a single NDA that includes Phase 3 data from one Dravet trial and two LGS trials. GW is on track to submit to the FDA in the first half of 2017.

In order to support GW’s NDA, the company expects to provide the FDA with data from ten Phase 1 and Phase 2 studies, as well as safety data from more than 1,800 patients in an expanded access program and pivotal programs which included 450 patients with one year or more of Epidiolex continuous exposure. This data is in addition to the pivotal efficacy data released on Sept. 28, 2016.

Epidiolex has obtained Orphan Drug Designation from the FDA for treatment of LGS, Dravet Syndrome, Tuberous Sclerosis Complex and Infantile Spasms. The Orphan Drug Act allows special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor.

GW’s cannabis plant-derived Epidiolex has helped the company’s stock soar to new highs in the lower $130s. FDA approval of Epidiolex could lead to world-wide sales of more than $1.0B in the next five years.

Epidiolex could be available in Missouri pharmacies way before Missouri voters could vote on another medical marijuana initiative. What would those Missouri prosecutors think of that?