Epidiolex is a nearly pure extract of cannabidoil (CBD), with little of the tetrahydrocannabinol (THC) that gets users high. CBD products are highly sought-after medicinal pot products, and activists fear that if the maker of Epidiolex gets FDA approval, it could undercut the political momentum of the medical marijuana movement.

A pediatric neurologist who oversees Epidiolex’s clinical trials at Nationwide Children’s Hospital in Columbus, Ohio, Anup patel, insists the drug contains the optimal known marijuana compound for treating seizures. He cited a study that found using the whole plant can hurt children.

Patel laments that children with epilepsy are being using to push for medical marijuana legalization, including during an unsuccessful Ohio ballot campaign last year.

“People are mixing terms, mixing ideas,” he said. “I’m not sure if that’s just because of confusion, lack of knowledge or on purpose.”

Karmen Hanson, expert on marijuana policy for the nonpartisan National Conference of State Legislatures, said the two sides are at odds.

“The argument for traditional (whole-plant) medical marijuana is that people know what works for them — whether they’re going to make their own concentrates or vape or combust, use flowered products, oils, you name it — so they want to protect their ability to do that,” she said. “The other camp wants to see the head-to-head science, to give it more scientific validity, to elevate the products that are produced in terms of reliability and consistency.”

Patel is in Camp 2. He personally lobbied to get U.S. patients access to Epidiolex, which he said is effective, consistent and doesn’t get users high.

Roughly two years ago, Patel persuaded GW Pharmaceuticals, a London-based company, to give him enough of the medicine for a single patient, and his hospital’s study was born. Last month, the company release positive results of late-stage testing. It plans to take Epidiolex to the U.S. Food and Drug Administration later this year.

THE FDA has not yet found any botanical form of marijuana to be safe or effective to treat any disease or condition, according to spokesman Michael Felberbaum. If Epidiolex is approved it would be the first, however, there are two synthetic cannabinoids – Marinol and Cesamet – available.

An FDA approval would allow any doctor to prescribe Epidiolex to any patient, and it would be covered by insurane. No law or ballot issue would be required.

Many medical marijuana activists fear the approval of Epidiolex will mark the beginning of Big Pharma’s takeover of the marijuana plant, undercutting patients’ ability to treat themselves as they see fit.

“We are not concerned with the pill (actually oil) form of a natural plant,” said Wendy Johnson, who represents the Cannabis Safety Association in Ohio. “In fact, it is looked upon very unfavorably and as a stumbling block on our way to whole plant.”

Twenty-three states now have medical marijuana and cannabis programs – but 17 others have chosen to permit use of “low THC, high cannabidiol” products, mostly cannabis oils or hemp extracts.

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Given that Epidiolex’s clinical trial success may mark the biggest advance for medical marijuana, we will have a better look about the study from GW Pharmaceuticals and its results.

A little background:

Americans attitude towards marijuana have been steadily improving over the course of the past twenty years. According to Gallup, 58% of Americans support marijuana legalization, up from 25% in 1995, and as a result, 23 states, including the District of Columbia (D.C.) have passed medical marijuana laws.

In those states, patients with a doctor’s approval, can be prescribed marijuana to treat various ailments, such as chronic pain and glaucoma.

Marijuana has long been touted by marijuana supporters as an effective medicine for these indications, however, placebo controlled, FDA-worthy studies that support marijuana’s benefits are hard to come by.

An important breakthrough:

GW Pharmaceuticals has been researching the use of medicine that is derived from the chemicals that are found in marijuana since the 1990s. Despite the company’s efforts spanning decades, the company has won regulatory approval for only one marijuana drug so far: Sativex.

Although Sativex is used to treat muscle spams in patients suffering from multiple sclerosis, it has arguably failed to become a commercial success. The company continues to spend millions researching the various chemical cannabinoids found in marijuana. As part of that research, GW discovered that CBD, a non-psychoactive chemical cannabinoid, may be effective in epileptics.

That discovery led to the creation of Epidiolex, a purified formulation of CBD extract, and the launch of studies in Dravet syndrome and Lennox-Gastaut syndrome patients. Dravet syndrome and Lennox-Gastaut syndrome are two forms of childhood epilepsy that is tough-to-treat and don’t respond well to current therapies, including anti-convulsants.

This week GW Parmaceuticals reported data from the first two Dravet syndrome studies, and the findings are very remarkable. Epidiolex reduced the number of monthly seizures in 120 randomized Dravet syndrome patients by 39%. For comparison, patients receiving a placebo only saw an 11% improvement in the number of seizures.

Moving forward

In the second half of 2016, the results of the second Dravet syndrome trial should be available. If that trial also succeeds, then an FDA filing for approval could come shortly thereafter.

Epidiolex has previously been granted FDA fast-track status, as such, a decision from the FDA would be expected to come six months after Epidiolex’s application for approval is accepted by the agency.

Without a doubt, an Epidiolex approval would be a big victory for patients struggling with this form of epilepsy. It would also be an achievement for the company and its investors, especially if results in Lennox-Gastaut syndrome patients are as successful. GW expects to report results from its Lennox-Gastaut studies later this year.

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