The Food and Drug Administration on Monday [June 25] approved the country's first drug derived from marijuana, a medication that treats two rare and devastating forms of epilepsy. The medicine is now approved in the U.S. for treatment of seizures due to Lennox-Gastaut and Dravet syndromes, which are both severe forms of epilepsy.
Epidiolex (cannabidiol) has been tipped as a potential blockbuster and the approval is the culmination of years of trials and development of the drug, which lacks the high associated with marijuana. "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)". The new drug, Epidiolex (GW Pharmaceuticals) comprises cannabidiol (CBD), a chemical compound in cannabis with potential health benefits, but does not contain tetrahydrocannabinol (THC), the compound in marijuana that causes intoxication.
Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). A scheduling change for CBD could potentially open the door for the approval of other cannabis-based medication in the future and help facilitate expanded marijuana-focused research.
The article does note that parents are giving their affected children "unregulated" CBD formulations, and although there are also other drug treatments and (although of unproven value) some efforts at surgery to abate the seizures, these offer less than good solutions, as the article notes. "Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes".
At the CU Skaggs School of Pharmacy, there are now a few drugs being tested - one for seizures and the other for Parkinson's tremors that are both are derived from cannabis.
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The DEA's stance that any extract from the Cannabis sativa plant is classified as Schedule I was recently upheld by the 9th U.S. Circuit Court of Appeals.
The most common side effects from the drug were sleepiness, diarrhea, insomnia, elevated liver enzymes cause mild liver injury and infections.
"And, the FDA is committed to this kind of careful scientific research and drug development". "This is how sound medical science is advanced". This classification conflicts with the FDA's approval of its medicinal use, and signals hope that this compound will soon find its way off the DEA's list.
GW is also developing Epidiolex in tuberous sclerosis, and if approved in the third indication, sales could break through the billion dollar annual sales barrier. Indeed, the FDA has been trying to crack down on CBD producers who make claims that their products can cure diseases like cancer. Catherine is part of the drug company's clinical trial.
This drug is also likely to be available made in the United Kingdom and Europe market from mid of 2019, though overtly subject to regulatory approval from European Medicines Agency in early next year.