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After the New England Journal of Medicine published the results of GW Pharmaceuticals’ (GWPH) Phase 3 study of Epidiolex, more people will know that cannabis does have medical benefits and should not a Schedule I substance.
Epidiolex is GW’s lead product candidate and has proven to be an effective treatment for epilepsy. Epidiolex is a liquid formulation of purified, plant-derived cannabidiol (CBD), which is being studied for the treatment of rare, severe pediatric-onset epilepsy disorders.
A Treatment with Massive Potential
Epidiolex has massive potential since there are currently no FDA approved treatments for Dravet syndrome, a rare form of epilepsy associated with a high mortality rate and significant developmental delays. GW’s study provided results that represent the only well-controlled clinical evaluation of a cannabinoid medication for this condition.
GW’s new drug application (NDA) for Epidiolex is expected and on track to be submitted to the FDA in the middle of 2017. The submission of this application will be a major milestone for the company and should be a catalyst for the stock.
A Highly Successful Study
The Phase 3 study randomized 120 patients and Epidiolex or a placebo was added to the patient’s current anti-epileptic treatment regimen. The average age of trial participants was 10 years and 30% of patients were less than 6 years of age. The patients involved in this study were taking approx. 3 anti-epileptic drugs and had previously tried and failed with 4+ other drugs.
The primary efficacy endpoint was a comparison between Epidiolex and placebo measuring the percentage change in the monthly frequency of convulsive seizures during the treatment period compared with the baseline observation period.
Patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39% compared with a reduction on placebo of 13%. The difference between Epidiolex and placebo emerged during the first month of treatment and was sustained during the entire treatment period. The proportion of patients who had a 50% or better reduction in convulsive seizure frequency was 43% with Epidiolex and 27% with the placebo.
The study provided incredible results and 62% of patients treated with Epidiolex saw an improvement in overall condition, significantly higher than the 34% from the placebo group. The results also showed that more patients became seizure-free on Epidiolex than placebo and total monthly seizure count was significantly reduced with Epidiolex
Outlook is Bright
GW is changing the landscape of the biotech industry. The company already sells a cannabis-derived treatment for multiple sclerosis is 27 countries and it has by far, the most advanced pipeline of cannabis-derived products in its pipeline.
We are favorable on GW Pharmaceuticals due its extensive pipeline of products in advanced stages of FDA testing, its balance sheet which is strong enough to support the cost of clinical trials, its impressive Wall Street coverage, and the $390 acquisition price placed on the company by Goldman Sachs.
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