Forbes reports on GW Pharmaceuticals getting closer to force the FDA to change its policy on cannabis.
Seems like the FDA will be forced to change their stance on CBD for seizures as trial shows positive results.
The results of the Phase 3 clinical trial on Epidiolex, the cannabidiol based medicine, were announced by the British biotech company, GW Pharmaceuticals.
Epidiolex was specifically developed to treat a rare form of epilepsy in children, Lennox-Gastaut syndrome. Trail results were very positive as 20mg of Epidiolex brought seizures down by 42% on average, compared to 17% on placebo. While on 10mg of Epidiolex, seizures dropped by 37% versus placebo’s 17%.
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GW Pharmaceuticals will now seek approval from the FDA by submitting a New Drug Application early next year. If Epidiolex gets approved, it will be the first drug with plant-derived cannabinoids to be approved in the US.
When the FDA approves a new drug application, the DEA must by law reschedule within 90 days, according to the Improving Regulatory Transparency for New Medical Therapies Act.
This means Epidiolex would be rescheduled by the DEA, but not marijuana. This adds some fuel to the already heated rescheduling argument. The matter becomes complicated because how can the DEA approve Epidiolex, a cannabinoid drug, as a medicine; yet still insist marijuana has no medicinal value?
This would not be the first controversy, as the US government already holds a medical patent on marijuana, but says it has no medicinal benefit.
The plot thickens
GW Pharmaceutical’s stock price shot up by 26% earlier this month because of buyout rumors, and is trading at $124 at the time of writing this article.
A Cowen & Company analyst predicts that, assuming Epidiolex gets approved, the drug will reach $1,1B through worldwide sales by 2021.
What about the “entourage effect”?
The Israeli researcher, Raphael Mechoulam, who determined the structure of cannabidiol (CBD) in 1963, wrote in 1999 that there are more than 480 natural components found within the cannabis plant, of which 66 are classified as "cannabinoids." These are chemicals unique to the cannabis plant, including THC or delta-9-tetrahydrocannabinol and cannabidiol or CBD, but there are many, many more.
Mechoulam often referes to the “entourage” effecti that may mean that the whole plant has a better effect than the isolated and synthesized compound. This effect was noticed in the 1980’s when the drug Marinol, which is pure synthetic THC, was developed.
CBD for seizures
CBD for seizures might still be most effective if the natural compound is used as it is found in nature rather than the isolated compound being synthesized. It is like eating a real fruit in comparison to taking vitamins.
This is an important point to remember as we move forward in the development of cannabis-based medicines. Unlike other medicines that work well by synthesizing a single compound in a lab, cannabis may offer its most profound healing when the whole plant is used, just as Mechoulam suggested two decades ago.