Potential Approval by the FDA of New Cannabis-Based Drug Used to Treat Rare Forms of Epilepsy

Despite continued animosity by U.S. Department of Justice regarding marijuana and marijuana-based products moving forward, at least one branch of the federal government has decided that the time is now right to at least consider the efficacy of certain medications that have their basis in cannabis.

U.K. company GW Pharmaceuticals Plc, has created a drug to treat seizures associated with two types of epilepsy that typically affect children and recently provided “substantial evidence” of the drug’s effectiveness to the Food and Drug Administration (FDA). The FDA confirmed this fact in a report released April 17, 2018. The FDA further stated that “The risk-benefit profile established by the data in the application appears to support approval of cannabidiol.”

GW Pharmaceutical’s drug is made from cannabidiol (otherwise known as CBD), a compound found within cannabis plants. This compound is not to be confused with tetrahydrocannabinol, or THC, which gives marijuana its euphoric effect. The drug is produced in the U.K. from a plant that has a high cannabidiol content. The chemical is extracted and purified before being crafted into an oral solution. If the FDA approves the drug, it could pave the way for other cannabis-based drugs.

As of April 2018, twenty-nine states and Washington, D.C., have passed laws legalizing medical marijuana. Approval by the FDA would provide patients with a therapy that would hopefully be covered by insurance. The proposed drug was developed to treat seizures associated with Lennox-Gastaut and Dravet syndromes, in patients age two and older. These particular syndromes are resistant to various other treatments and Dravet syndrome has a mortality rate of almost 20 percent in children with syndrome, most of whom pass away before reaching adulthood.

It is anticipated that the FDA will decide whether to approve the drug by June 27, 2018. If it is approved, it may be the start of the federal government changing its stance as to marijuana and its potential medical benefits. As of April 26, 2018, there are at least five pieces of proposed legislation pending that seek to remove marijuana from the federal government’s controlled substances act, and specifically remove its Schedule I designation. Given the proliferation of marijuana dispensaries and manufacturers at the state level and the large scale growth of the cannabis industry internationally in locations such as Canada and Germany, it would only benefit the federal government if it were to move forward with the full legalization of marijuana. The potential tax benefits and massive growth within the industry are a testament to the drug’s ability to provide relief to millions of people suffering from various illnesses. If the FDA does approve GW Pharmaceutical’s drug, it will be another step forward in removing cannabis from the Controlled Substances Act and legalizing its use both medically and recreationally across the U.S.

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