The US health regulator approved GW Pharmaceuticals Plc's epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis.
The North American Marijuana Index closed mixed on Tuesday following this week's news that GW Pharmaceuticals (NASDAQ:GWPH) won FDA approval for their CBD-based drug Epidiolex. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
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The drug, Epidiolex, is derived from cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive component that makes people high. This includes seizures from two types of rare epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.
So how do you get medical marijuana treatment in Southwest Florida? The trials included 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome.
Given that CBD is an ingredient in marijuana, people often confuse it with taking "regular" marijuana. Alan also expects that there will be more CBD products and other medications derived from cannabinoids on the market.
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Most patients with LGS and Dravet require several drugs and are resistant to many now approved epilepsy drugs. FDA staff said at an April meeting on the drug with outside advisers that cannibidiol, known as CBD, "does not appear to have abuse potential".
"DEA is required to make a scheduling determination".
The most common side effects from the drug were sleepiness, diarrhea, insomnia, elevated liver enzymes cause mild liver injury and infections. FDA chief Scott Gottlieb said his agency had supported research on cannabis-derived products "for many years". Perhaps in anticipation of an onslaught of unfounded medical claims, Gottlieb warned that his agency will "continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims". "The conditions it is approved to treat are devastating and hard to control and so rightly got the attention of pharmaceutical companies and regulatory agencies", he says. They're defined as substances with high abuse potential and "no now accepted medical use". But that is not necessarily the case and readers with an interest in this drug would be better informed if some of the clinical trial evidence had been included in the story. GW's subsidiary Greenwich Biosciences will market the drug in the US. As noted in the FDA's announcement approving Epidiolex, "m$3 arketing 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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