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FDA approves first marijuana-based epilepsy medication

FDA approves first marijuana-based epilepsy medication

The FDA approved Epidiolex to be used for patients that have Dravet and Lennox-Gastaut syndromes, the two rare forms of epilepsy that have a limited treatment. "Lennox-Gastaut Syndrome is a devastating form of epilepsy, and despite now available FDA-approved medications and a poly-therapy approach to treatment, the majority of individuals with LGS will continue to have life-long, debilitating seizures, along with cognitive impairment and an abnormal brain waves on EEG (electroencephalogram)".

Recent data suggests that it can potentially treat seizures, including Dravet syndrome and Lennox-Gastaut syndrome.

The U.S. Food and Drug Administration (FDA) yesterday approved the first drug derived from marijuana.

The drug's effectiveness was studied in clinical trials with 516 patients and when taken with other medications, Epidiolex was shown to be effective in reducing the frequency of seizures when compared with placebo.

The FDA noted in its announcement that it informs and advises the DEA about scheduled substances and is expected to advise the DEA to reclassify CBD in the coming weeks.

While Epidiolex is the first approved medicine that comes from a pot plant, the FDA has allowed the use a few drugs made from synthetic cannabinoids, including Insys Therapeutics Inc's Syndros for loss of appetite in people with AIDS and nausea caused by chemotherapy. The drug went through several phases of clinical trials, all of which confirmed the efficacy and safety of the drug in treating the symptoms of these disorders, before finally gaining federal approval.

The drug is an oral solution derived from cannabis.

Iran lists demands for improving relations with US
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Cannabidiol is one of more than 80 active cannabinoid chemicals, yet unlike tetrahydrocannabinol, or THC, it does not produce a high.

USFDA Commissioner Scott Gottlieb said the approval of the drug was "an important medical advance".

Having an FDA-approved, pharmaceutical-grade CBD drug will open up a new treatment option for epilepsy patients by delivering a high-quality, consistent dose of CBD, says Robert Carson a pediatric neurologist at Vanderbilt University who treats patients with epilepsy.

But Dr. Gottlieb also held out the possibility of more approvals for marijuana-based drugs down the road.

Some have said that they have no intention of switching to the new prescription CBD drug because the products they're using are helping their children.

"And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition", he continued.

He said, "Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".

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