In three large clinical trials which the FDA considered before giving Epidiolex the official green light, researchers presented strong evidence that the pharmaceutical-grade CBD in the medicine had the power to significantly curb some of the worst symptoms of two of the hardest-to-treat forms of epilepsy, known as Lennox-Gastaut syndrome and Dravet syndrome. However, Epidiolex is the first FDA-approved medicine containing plant-derived, non-synthetic cannabinoids.
Before sales of Epidiolex can begin, the Drug Enforcement Administration must formally reclassify CBD into a different category of drugs that have federal medical approval.
"This is an important medical advance", Gottlieb said. The drugmaker is testing other CBD treatments for glioblastoma and schizophrenia.
FDA Commissioner Scott Gottlieb said the agency "will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products".
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Although THC can induce paranoia, anxiety and hallucinations, CBD has the opposite effect and has been cited by scientists as a potential treatment for mental health issues. "I am delighted that my physician colleagues and I will now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and been approved by the FDA to treat both children and adults".
Why? Because their product and company status will no longer exist in the legal gray area, and hopefully the mass confusion over which CBD products are legal and which are not will come to an end.
GW Pharmaceuticals makes the drug in the United Kingdom from cannabis plants that are specially bred to contain high levels of CBD. "There's no time line or clock that starts ticking on us".
"Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", he said.
That's according to Steve Fox, the director of VS Strategies, which was retained by GW Pharmaceuticals to assist with lobbying and public relations efforts.
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The FDA is not required to follow the advisory panel's advice but usually does. The company has pushed legislation in several states to make sure its drug can be legally sold and prescribed.
Dravet syndrome is a rare genetic condition that causes frequent fever-related seizures, involuntary muscle spasms and a potentially life-threatening state of continuous seizure activity requiring emergency medical care.
The FDA's decision was expected.
For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market. A bill was introduced to the House previous year to legalize the use of marijuana, but it has yet to reach the floor for vote.
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