After GW Pharmaceuticals plc (GWPH) reported that its marijuana based medicine Epidiolex reduced seizures in patients with a rare form of epilepsy, medical marijuana advocates are breathing a sigh of relief. Why? Because 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 yet, let's learn more about GW Pharmaceuticals study and its results.
First, a bit of background
Over the past twenty years, Americans attitude toward marijuana has been steadily improving. According to Gallup, 58% of Americans support the legalization of marijuana, up from 25% in 1995, and as a result, 23 states, including D.C. have passed medical marijuana laws.
In those states, doctors can prescribe patients marijuana to address various indications, such as chronic pain and mood disorders.
Marijuana has long been touted by marijuana supporters as an effective medicine for these indications, however, placebo controlled, FDA-worthy studies backing-up marijuana's benefits are hard to come by.
An important win
GW Pharmaceuticals has been researching the use of medicine that is derived from the chemicals that are found in marijuana since the 1990s. However, despite efforts spanning decades, the company has won regulatory approval for only one marijuana drug so far: Sativex.
Although Sativex, which is used to treat muscle spasms in multiple sclerosis patients, has arguably failed to become a commercial success (sales are roughly $5 million per quarter), the company continues to spend millions researching the various chemical cannabinoids found in marijuana. As part of that research, the company 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 tough-to-treat forms of childhood epilepsy that don't respond well to current therapies, including anticonvulsants.
This week GW Pharmaceuticals reported data from the first of two Dravet syndrome studies, and the findings are pretty remarkable. In 120 randomized Dravet syndrome patients, Epidiolex reduced the number of monthly seizures by 39%. For comparison, patients receiving a placebo only saw an 11% improvement in the number of seizures.
Results from a second Dravet syndrome trial should be available in the second half of 2016 and if that trial also succeeds, then an FDA filing for approval could come shortly thereafter.
Because Epidiolex has previously been granted FDA fast-track status, a decision from the FDA would be expected to come six months after Epidiolex's application for approval is accepted by the agency.
Unquestionably, an Epidiolex approval would be a big victory for patients struggling with this form of epilepsy. It would also be a big victory for the company and its investors, especially if results in Lennox-Gastaut syndrome patients are as successful. The company expects to report results from its Lennox-Gastaut studies later this year.