Most patients with LGS and Dravet syndrome require multiple seizure medications and the majority are resistant to now approved anti-epileptic drugs. In one study of 120 children and young adults with Dravet syndrome, cannabidiol reduced the median frequency of convulsive seizures to 5.9 a month from 12.4 before treatment, while patients getting a placebo saw minimal reductions, according to results published past year in the New England Journal of Medicine. In some cases, patients have moved to states that have legalized medical marijuana in order to have access to the drug.
"The DEA will need to make a different scheduling decision for CBD.because it now has an accepted medical use", he said during a conference call with reporters. We are hopeful that the new GW drug will help many people with the two diseases it is approved for and for whom insurance will cover the drug.
"There is some research that indicates that CBD specifically could interact with other medications such as statins, and increases the amount of those medications in the blood", Chadi said. Although a synthetic version of THC, marijuana's main psychoactive ingredient, has been legally available as a treatment for nausea and appetite loss since 1985, this is the first time the federal government has given its blessing to a medication derived directly from cannabis.
The component in this newly approved drug is CBD (cannabidiol), which is part of the sativa marijuana plant.
Cannabidiol (Epidiolex), an oral solution to treat seizures in Lennox-Gastaut Syndrome (LGS) and Dravet syndrome, was approved for patients two years of age and older. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions. "I really don't think [the FDA approval is] going to affect us much". GW Pharmaceuticals has monitored Epidiolex' effects on over 500 children and adults who are afflicted with seizure conditions that are hard to treat using traditional medications for epilepsy.
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The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the USA subsidiary of GW Pharmaceuticals.
Epidiolex will be marketed by Greenwich Biosciences, a subsidiary of GW Pharmaceuticals.
For those who have long argued that cannabis offers medical benefits, the FDA approval represents a milestone, "a recognition that the plant is a rich source of compounds which have potential therapeutic activity", Justin Gover, chief executive of GW Pharmaceuticals, the London-based company that developed the drug, said in an interview last week.
Epidiolex is under review in Europe as well, and GW expects a decision from the European Medicines Agency in the first quarter of next year.
Many companies sell cannabis-based treatments, touting them as cancer cures, pain relievers and anxiety medicines.
The FDA's first approval of a cannabis-derived compound happened thanks to sound science, and it must proceed that way.