After GW Pharmaceuticals reported that its marijuana based medicine Epidiolex reduces seizures in patients with a rare form of epilepsy, medical marijuana advocates are breathing a sigh of relief. High profile trials evaluating marijuana in cancer pain came up short last year, casting doubt on the ability to prove marijuana’s medical benefits in scientific studies.
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.
