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Last week, the Food and Drug Administration (FDA) approved Epidiolex® (Cannabidiol, or CBD), a marijuana-derived drug, for the treatment of two serious epileptic disorders, Lennox-Gastaut's syndrome, and Dravet syndrome. CBD is a compound that is usually found in very small amounts in the marijuana plant, and it has been of interest to scientists and the public for many years because of its anti-epileptic properties and other therapeutic benefits possible. The approval comes at the end of a series of four-year trials showing the benefits of CBD for relieving the symptoms of these epileptic disorders, which are highly resistant to existing treatments.
The syndromes of Lennox-Gastaut and Dravet are extremely debilitating. Children often suffer from multiple seizures a day, they are likely to have developmental problems and have a high risk of early mortality. For many years, desperate parents whose children were suffering from these disorders were sometimes resettled in states where marijuana had been legalized for CBD oils, as this compound had been reported anecdotally as useful.
But medical marijuana products are still not subject to the same federal safety regulations that govern pharmaceuticals, there is no guarantee that CBD oils are accurately labeled or contain any contaminants ; Similarly, with such products, it may not be possible for a patient or his caregivers to accurately control the dose or even to know what dose is being administered. Epidiolex, an oral solution that should be available to patients in the fall of 2018, will be safer and more reliable than CBD products currently available in marijuana dispensaries or on the internet.
In 2014, GW Pharmaceuticals, a British company specializing in cannabinoid-based drugs, obtained the Fast Track designation for their FDA drug, in order to accelerate the development of a drug capitalizing on the anti-epileptic properties of CBD. Three randomized clinical trials were conducted in 516 children with Lennox-Gastaut syndrome or Dravet syndrome.
In April of this year, an FDA advisory panel composed of experts from across the country (including a representative of the NIDA) Medical Consequences) evaluated the evidence of trials and voted at the same time. unanimously to recommend the approval of Epidiolex®, given its effectiveness in reducing the frequency of seizures (compared to placebo) and the fact that the drug seems safe, with mild or infrequent side effects.
Epidiolex® is the first drug approved by the FDA made from a purified extract of the marijuana plant. Two other FDA-approved drugs, dronabinol and nabilone (used to treat nausea caused by chemotherapy and stimulate appetite in AIDS patients, respectively), contain synthetic versions of THC, the compound of marijuana responsible for its addictive power.
Destroying the harmful effects of THC from its potentially therapeutic properties (for example in the treatment of pain and nausea) has been a challenge in the development of safe drugs that target the body's endocannabinoid system. CBD, which interacts with other signaling systems and does not have the same annoying or euphoric side effects, faces fewer safety hurdles. Another marijuana drug manufactured by GW Pharmaceuticals, Sativex®, consists of equal parts of THC and CBD and is approved in the UK for treating spasticity, neuropathic pain and other symptoms of multiple sclerosis. in plates; it has not been approved in the United States.
The approval of Epidiolex® last week is an important step in the development of safe and effective cannabinoid-based drugs for patients. It also offers new hope to parents of children with two particularly devastating neurological disorders.
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