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FDA Trial of Marijuana Drug Epidiolex – On Track for Approval?

GW Pharmaceuticals (Nasdaq: GWPH), a UK based biopharmaceutical company, has announced impressive new FDA clinical trial results for its cannabis (marijuana) based drug, EpidiolexEpidiolex is being studied as a potential treatment for rare forms of childhood epilepsy, namely Dravet and Lennox-Gastaut syndrome (LGS). The drug could represent a life-line to children suffering from this intractable form of epilepsy. It may also represent a milestone in cannabis medical research, and a sign of things to come in the burgeoning legal cannabis industry.

Cannabis contains over 100 known pharmacologically active substances called cannabinoids. Cannabinoids are known to influence the Endocannabinoid system in the human body and have been shown to produce a multitude of beneficial health effects (pain suppression, anti-tremor, anti-nausea, anti-oxidant, anti-inflammatory, anti-spasmodic, neuroprotective, etc.). THC and CBD are the two most widely studied cannabinoids. Both are known to have anticonvulsant and neuroprotective properties (Devinsky et. al, Journal Epilepsy – June, 2014) and are now being considered as potential adjunct therapies for a variety of neurological disorders, including (PTSD Alzheimers, multiple sclerosis, Huntington’s disease, Parkinson’s disease, and many others). For more details, see my blog post entitled

Your Brain on Cannabis

Cannabidiol: Good for You and Your Brain?“.

Epidiolex contains a highly purified, plant derived form of CBD. It is not a synthetic cannabinoid, like Marinol (anti-nausea Rx). It is a highly purified derivative of cannabis plant extracts. Since Epidiolex contains no THC (not that there is anything wrong with THC), the drug has few noticeable side-effects. And unlike THC, CBD is non-psychoactive and will not produce the intoxicating high that marijuana is known for. The lack of a psychoactive effect is a big reason why medical researchers are so excited about the potential for CBD based medicine.

GW Pharmaceuticals received orphan drug designation by the FDA in 2014, enabling it to start clinical trials to determine the efficacy for treatment of Dravet, Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis Complex (TSC). Now in late stage trials, the results are coming in and they are very impressive. After 12 weeks of treatment, almost half (47%) of all patients treated with Epidiolex saw a better than 50% reduction in the frequency of their seizures! That’s huge! Plus the drug was very well tolerated. Less than 5% dropped out of the study due to perceived side-effects from the drug.

 

 

 

Sativex from GW Pharmaceuticals

GW is not a new entrant into cannabis based pharmaceuticals. Quite the opposite actually. The GW lead product is a cannabis based medicinal called Sativex, perhaps you have heard of it. Sativex contains both principal cannabinoids THC and CBD, along with other cannabinoids and non-cannabinoid plant ingredients. Sativex is approved for treatment of multiple sclerosis in 27 countries. In the US, GW is pursuing FDA Phase 3 trials for the use of Sativex as a treatment for multiple sclerosis, as well as for the relief of cancer pain.

Although I’m impressed with what GW has been able to accomplish with such a complex biological extract, I’m dismayed at GWs social/political stance with respect to medical marijuana in the US.

From GW Pharmaceuticals:

“Is GW supportive of state medical marijuana programs and the use of herbal cannabis – smoked or otherwise – as medicine?

No. GW supports the evidence-based approach to developing new medications according to the FDA approval process.”

In my opinion, the healing properties of cannabis exist independently of their being co-opted by big pharma and validated by the FDA. To withhold this natural pain-suppressant, while endorsing dangerous alternatives, is unconscionable and not aligned with the public good that the DEA and FDA are sworn to protect. For GW to stand in support of the FDA processes and federal bureaucracy that has marginalized medical cannabis use and research, while profiting from marijuana’s effectiveness and safety profile – is more than disappointing.

The Controlled Substances Act (CSA) was enacted in part due to international concerns over heroin and opioid abuse. Unfortunately, the remedy proposed at the time – the War on Drugs, did little to stem opioid drug abuse or deaths from prescription drug overdoses. Cannabis was included as a controlled substance in the CSA, in large part at the behest of President Nixon, for largely ideological and political reasons. It’s time to end the ban on open research permanently, and reschedule cannabis to a Schedule III.

For more details on how cannabis ended up as a Schedule I controlled substance, plus a chance to see hear President Nixon speak from the Oval Office on Marijuana, consider reading my blog post entitled "DEA to Reschedule Weed - What You Need to Know - Part I".

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