The expanding number of CBD-only medical marijuana laws is setting the stage for some dramatic changes in the medical cannabis issue. Recent actions by the Food and Drug Administration (FDA) clearly reveal the federal government’s intent to rush-to-market a pharmaceutically-prepared rival for the now infamous Charlotte’s Web CBD oil. The drug is called Epidiolex and while it may be produced by a well-established pharmaceutical company, valued at $1.4 billion, the drug is created in much the same way that CBD oil is created in the legal medical marijuana states — from natural cannabis.
Epidiolex, produced by the British company GW Pharmaceuticals, has been granted two important status criteria by the FDA: orphan drug status and permission to use the expanded access investigational new drug (EA IND) process. Orphan drugs are designated for rare or little-known diseases, such as Dravet syndrome. According to Wikipedia, “it is easier to gain marketing approval for an orphan drug, and there may be other financial incentives, such as extended exclusivity periods, all intended to encourage the development of drugs which might otherwise lack a sufficient profit motive.”
The second status criteria is the game changer. The EA IND process is replacement terminology for the old compassionate IND program that once allowed dozens of individuals to obtain legal access to government marijuana in the 1980s and 1990s. The marijuana program was closed by the first Bush administration in 1991 but the concept (expedited access for critically ill patients to unapproved drugs) has re-emerged as the EA IND. Expanded access, according to FDA, is “the use of investigational new drug products outside of clinical trials to treat patients with serious or immediately life-threatening diseases or conditions when there are no comparable or satisfactory alternative treatment options. The rules and regulations related to expanded access are intended to improve access to investigational drugs for patients who may benefit from investigational therapies.”
Epidiolex was granted expanded access status in early June and, according to the GW website, there are already more than 300 patients authorized to be treated under the EA IND.
Even more impressive is the fact that GW has reached agreements with at least two states to provide Epidiolex. In New York, Governor Cuomo signed an agreement with GW a month before he signed the medical marijuana law that made New York the 23rd state acknowledging the medical utility of cannabis. GW is arranging a similar agreement with the state of Georgia (which does not have a CBD law) and is, no doubt, talking with health authorities in the other CBD-only states.
Epidiolex has already been tested and has had its results released. The research shows significant improvement for a large percentage of Dravet syndrome victims with 33 percent becoming seizure free by the end of the 12-week study. The company calls its CBD “pure” with no trace of THC. For some in the medical cannabis community that is downside. They believe a small percentage of THC is essential to reach the maximum therapeutic value of CBD oil.
But, my guess would be that Epidiolex will work for the greatest percentage of Dravet syndrome patients and will be nationally available in 2015. This will effectively remove those families from the medical cannabis arena and going with them will be a lot of the energy that has driven the issue for the past two years.
As I said, a game changer.
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