Following a successful trial in May that proved the drug reduced seizure frequency by 40 percent, Epidolex will become the first FDA-approved medicine to include cannabidiol, or CBD, a non-psychoactive chemical found in the marijuana plant.
Many parents already are giving children unregulated CBD formulations that are available in medical marijuana dispensaries in the many states where such operations are legal.
GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy.
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"For those living with intractable seizures caused by LGS and Dravet syndrome, Epidiolex represents a true medical advancement", said Philip Gattone, president and CEO of the Epilepsy Foundation. "But it's also important to note that this is not an approval of marijuana or all of its components".
Now with the approval of Epidiolex, a drug that will not produce an euphoric "high" feeling in the user - Devinsky said he expected CBD would be moved down to a schedule 4 or 5 drug, which is one that poses a low potential for abuse and dependence. "And, the FDA is committed to this kind of careful scientific research and drug development", FDA Commissioner Scott Gottlieb, M.D, said. This is not only the first drug that contains substances from marijuana, but it is also the first drug aimed to treat Dravet syndrome.
"I preferred this to some of those other options because it's is a commercial product that has gone through rigorous testing", said Hendershot, who lives in Rochester, New York.
Dravet syndrome is a rare genetic condition that usually shows up in infants, starting with fever-related seizures and progressing to other, more severe seizure types.
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The approval could spur more research into marijuana products, though marijuana itself remains illegal.
The FDA previously issued warnings to CBD producers that claimed their products could treat specific diseases, such as cancer or Alzheimer's.
Epidiolex is also the first prescription created to treat children with Dravet syndrome, according to the FDA's announcement.
The FDA is not required to follow the advisory panel's advice but usually does.
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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. Shinnar said he will welcome approval of a medicine that had undergone stringent FDA review for safety and effectiveness. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. But GW said it expects that the DEA will reschedule CBD within 90 days. The administration would then presumably reclassify cannabidiol in a less restrictive schedule (the DEA has five drug schedules, with Schedule I being the most restrictive and Schedule V being the least restrictive). "This is how sound medical science is advanced".