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FDA Recently Approves First Cannabis-Based Drug

On July 25, 2018, the U.S. Food and Drug Administration approved a CBD oral medication called Epidiolex for use in the treatment of seizures in conjunction with two severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients ranging from 2 years of age and up.

This marks the first FDA-approved drug that contains purified substance cannabidiol, an active chemical in marijuana, and also the first FDA approved the drug for Dravet syndrome. Because there is growing interest in using medical marijuana to treat a variety of mild to severe medical conditions, including but not limited to glaucoma, AIDS, cancer, chronic pain, multiple sclerosis, chemo-related nausea and others.

CBD is a component of marijuana that does not contain THC, the component that gets you high. THC is the cannabinoid that releases a euphoric or intoxicating feeling and is the primary psychoactive component of marijuana. Due to its lack of psychoactive elements, CBD can skirt around the ban on marijuana. From a medical and legal perspective, CBD can be sold or used legally as long as it has a low amount of THC, depending on your state’s laws.

Cannabis sativa contains over 80 kinds of cannabinoids, and these cannabidiols are potent medicine and are legal almost everywhere.

The FDA currently approving a cannabinoid as an active ingredient in a drug serves as the first point in other programs using active ingredients in marijuana for medical therapy. This is also an important step in the FDA being committed to further studying and conducting trials for research and drug developments. Clinical and controlled studies are an important element in varying the benefits and effectiveness of marijuana-derived products. This commitment to supporting scientific research is an important milestone in viewing marijuana and marijuana products as having valid medicinal and health benefits, which could ultimately lead to utilizing it to treat serious diseases and chronic pain.

Dravet syndrome is a rare, catastrophic and lifelong disease that begins in the first year of life with frequent and prolonged fever-related seizures. Frequent and prolonged seizures at such a developmental age can result in behavioral, motor, developmental delays. Additionally, patients suffer sleeping difficulties, eating and nutrition issues, and have difficulty regulating body temperature and sweating. Later in life, these frequent, prolonged seizures turn into other type of seizures, including myoclonic seizures (involuntary muscle spasms). Currently, treatment options are limited. Since this is a lifelong condition and the patient needs constant care, family life and quality of life are impacted.

Lennox-Gastaut syndrome is a form of severe epilepsy that also begins in childhood. People with this syndrome usually start having frequent seizures between the ages of 3 and 5. More than three-quarters of patients have tonic seizures, which is uncontrollable muscle seizures. Most of these seizures occur during sleep. Common seizures include atypical absence seizures, which cause a partial or complete loss of consciousness. Drop attacks are also common, where the patient experiences a sudden episode of weak muscle tone, resulting in falling suddenly. These drop attacks can be serious or life-threatening injuries. Living with these seizures causes developmental and learning delays, and most children have an intellectual disability that correlates to their seizures. Constant care and help may be a byproduct of any neurological abnormalities or behavioral problems, but a small percentage of adults are able to live independently.

“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” according to Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”

The study of Epidiolex includes three randomized, double-blind, placebo-controlled clinical trials involving over 500 patients with either syndrome. Other medications were also tested and Epidiolex was shown to be effective in reducing seizure frequency.

Using marijuana in a medicinal capacity is a healing and important process for people who want a potent, effective and pill-free treatment for chronic, severe and incapacitating diseases.

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