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Epidiolex, the first cannabis-based medication approved by the US Food and Drug Administration, is now available by prescription in all 50 states.
The twice-daily oral solution is approved for use in patients 2 and older to treat two types of epileptic syndromes: Dravet syndrome, a rare genetic dysfunction of the brain that begins in the first year of life, and Lennox-Gastaut syndrome, a form of epilepsy with multiple types of seizures that begins in early childhood, usually between ages 3 and 5.
“Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures,” said Justin Gover, CEO of GW Pharmaceuticals, the maker of Epidiolex, in a written statement. “We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.”
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Epidiolex was recommended for approval by an advisory committee in April and approved by the FDA in June. In September, the US Department of Justice and the Drug Enforcement Administration classified Epidiolex as a Schedule V substance, clearing the final hurdle for it to be legally prescribed by doctors in the United States. (Marijuana and CBD remain Schedule I substances.)
“Adequate and well-controlled clinical studies supported Epidiolex’s approval, so 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,” FDA Commissioner Dr. Scott Gottlieb said in a written statement. “The FDA will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and stand ready to work with product developers who are interested in bringing patients safe and effective, high quality products.”
Dr. Orrin Devinsky, director of the Comprehensive Epilepsy Center at NYU Langone Health, served as the lead investigator of two of three phase three clinical trials of Epidiolex.
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“In those syndromes, when [Epidiolex] was added to three other seizure [medications], on average, it reduced convulsive seizures — or ‘drop seizures’ — by about 25% to 28% compared to a placebo,” Devinsky said. “So I think it’s very important to recognize … that it clearly is effective, and this was statistically significant in all three of the large studies that we did, but by the same token, the effect was modest.
“There are some people who had dramatic improvements. Many had a modest improvement, and some had no improvement. So it’s not a miracle drug. It’s an effective drug, and I think its side effect profile is quite good compared to other seizure drugs that we have, but it’s not a miracle cure,” Devinsky said.
The most common side effects of Epidiolex, according to GW Pharmaceuticals, include sleepiness, decreased appetite, diarrhea and an increase in liver enzymes.