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GW Pharmaceuticals Issues Year-End Report

A pot leaf next to a syringe represents how GW Pharmaceuticals has taken on CBD pain killers.

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GW Pharmaceuticals Issues Year-End Report

GW Pharmaceuticals, the 16-year-old British pharmaceutical company that has focused its energies on the development of pharmaceutical-grade cannabinoid products, has gone through a major transformation according to its fourth quarter, fiscal year-end report.  The company’s chief executive officer, Justin Gover, hailed his company’s success with Epidiolex, a highly purified form of the CBD-only cannabis strains that seem to have taken the country by storm in 2014.

The tone of the report seems especially upbeat with the CEO declaring, “In 2015, we expect to complete much of the Epidiolex development program as well as start to build a U.S. commercial presence in anticipation of future launch.”

Mr. Gover noted that the company has “commenced treatment of approximately 200 children,” although his estimate downplays the actual number of recipients. One year ago, while announcing Epidiolex’s designation as an “Orphan Drug” by the Food and Drug Administration (FDA), the company reported there were seven study sites with a total of 125 patients.

This year’s report reveals more than 400 patients at 20 “expanded access sites,” most likely private physicians with several patients each or perhaps acting as a regional Investigational New Drug (IND) holder. Another 200 patients, probably those referred to by Mr. Gover, are receiving Epidiolex at “11 clinical sites in the U.S.” It’s likely these are academic institutions such as Texas Children’s Hospital, the University of California at Los AngelesNew York University and University of California as San Francisco.

These sites are the workhorse studies for GW and offer a chance to administer the drug using “good clinical practices,” whereas the expanded access sites provide only anecdotal evidence since they aren’t controlled in a true scientific sense (i.e. double-blind studies). These studies are dual-edged for GW. Once known as Compassionate INDs, the studies, in GW’s words, “may lead to … clinical trials that are not adequately designed to demonstrate efficacy and could delay or prevent GW’s ability to seek approval of Epidiolex.”

This bit of legalese is theoretically true but Epidiolex has already won Fast Track approval from FDA and barring unforeseen and severe adverse side-effects (which would be immediately reported to FDA) it’s unlikely anything will delay approval of Epidiolex for marketing.

Additionally GW has signed contracts with two states, New York and Georgia, to hold clinical trials in those states for children and young adults with rare forms of epilepsy.

The report also contained information on Sativex, GW’s oral mucosa spray product that is approved in 27 nations (not the U.S.) and currently available in 15 countries for treatment of multiple sclerosis (MS). GW has been testing the drug for pain related to cancer and the drug will enter Phase 3 studies in 2015. Like Epidiolex, Sativex has received Fast Track designation from the FDA for this indication. Surprisingly, GW seems to have backed off from its pursuit of FDA approval to market Sativex for MS in the U.S.

Finally, the GW report highlighted some of its pipeline products with some exciting possibilities. These include another epilepsy drug called GWP42006. It’s also referred to as Cannabidivarin (CBDV) and will begin phase 2 studies in 2015.

A drug listed as “GWP42002:GWP42003” is being studied for use in the treatment of glioma (a brain or spinal tumor) and is advancing to the second phase of testing. Some exciting early data from St. Georges University in London suggests there’s a synergistic effect when combining cannabinoids with radiotherapy.

GWP42003, flying solo, is being studied for the treatment of ulcerative colitis. Initial trials show promising signals of efficacy in patients who completed the course of treatment. The same drug is also being looked at for treatment of schizophrenia but all studies are in Europe.

Lastly, GW has begun looking at type-2 diabetes and its new drug GWP42004. Completion of those studies, all of which are located in the United Kingdom, is expected in 2016.

For those interested in more information about GW’s ongoing and completed studies the best source is the U.S. Government’s ClinicalTrials.gov, a service of the U.S. National Institutes of Health.  For general information on GW’s products, check out the GW website.

Would you use cannabis-based pharmaceutical products to help ease your symptoms? Share your thoughts in the comments below.

6 Comments

6 Comments

  1. Alice O'Leary-Randalll

    December 30, 2014 at 1:12 pm

    I’d have to agree, Racheal.

  2. Mike manfredo

    December 23, 2014 at 5:55 pm

    Yes, I absolutely would use a product for relief and help for a illness, disease, or pain. I can’t wait till your products are available in the usa. Please keep pushing the usa to accept these exciting options

  3. NorCalNative

    December 23, 2014 at 3:56 pm

    Alice, my answer would have to be YES and NO.

    Yes if I didn’t have access to a company called “Care By Design” which produces products that mimic the work of GW Pharmaceuticals, and NO because I DO have access to a company called “Care By Design.”

    One might quibble over the difference between Sativex (2.7 mg THC and 2.5 mg CBD) as compared to Care By Design’s version at an equal 2.6 mg of both THC and CBD but I wouldn’t include myself in that bunch.

    And, the dispensary versions of the pump-spray delivery bottle uses coconut-oil as the base rather than mucous-membrane irritating alcohol that’s in Sativex and Epidiolex.

    To top it off, the dispensary version is approximately 5X cheaper than what GW Pharmaceuticals charges for Sativex. So, at least in California, the future is HERE NOW. NO need to wait on FDA’s approval schemes and pace when you can medicate with a pharmaceutical-grade product NOW.

    And, with 5 CBD-rich options (1:1, 2:1, 4:1, 8:1, and 18:1) one or more of those ratios should work for most medical problems that can be benefitted by cannabis-based therapeutics.

    I’m not a part of the Care By Design operation or sales force, but maybe I should be because I’m confident and convinced they’ve got a bunch of winners in their product line. They also offer a vape-pen cartridge rich in CBD as well as the traditional plastic syringe that’s well-known to users of Rick Simpson oil.

    To your point about easing symptoms, in the last year I’ve used the full extract cannabis oil in the high-THC versions to eliminate EVERY BIG PHARMA medicine I was using including ending a 20-year-dependcy on morphine. That is, the full extract oil replaced a narcotic analgesic, assorted NSAIDS, Amitriptyline, Glucosamine and even statin medication.

    I had trouble with dose titration using the plastic syringes so I really appreciate getting the same amount of medicine with each push on the spray bottle and especially the chance to include CBD into the mix. For my neuropathy and osteoarthritis the 1:1 ratio (Sativex-like)is my pick.

    I’m not a big fan of the idea of the pharmaceuticalization of cannabinoids but have to admit that I’ve found the studies and research of GW Pharmaceuticals to be of great value in combination with all the other studies and research that can be found on PubMed.

    If you reside in Colorado you’re probably aware that there’s a certain set of Mormon brothers (The Stanley’s) that have pissed off a lot of patients and dispensary owners with the way they turned their backs on THC. The terrible irony of Charlotte’s Web-based oil is that the Figi’s got their initial info from a California man with a son with Dravet Syndrome. While the Stanley Brothers plant is a remedy for Charlotte at something like 20:1 ratio of CBD-to-THC, that same ratio for Jayden David of the family the Figi’s consulted with gave him his WORST SEIZURES and what works for his symptoms is a 6:1 ratio.

    One-size-certainly-does-not-fit-all and the damage done by CBD-only legislation spurred by CNN and Sanjay Gupta is extremely problematic for the future of patients in the U.S..

    Thanks for a great post Alice, and you should know that people who are aware of who your late husband was appreciated his role in this battle. I think I need to check out your book.

    • Alice O'Leary-Randalll

      December 30, 2014 at 1:12 pm

      Thanks NorCalNative for such a thoughtful response. I am familiar with Project CBD and they have great products. Unfortunately I live in Florida so I can’t take advantage of the great work they have done, along with many other great entrepreneurs in the legal/medical cannabis states. FDA has sadly deteriorated into a tool of Big Pharma and I applaud GW for stepping up to the plate to show that cannabis can pass muster, however silly it might be. The system is so complex it completely boggles the mind.

  4. racheal turner

    December 22, 2014 at 10:42 pm

    I think it is an awesome thing

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