The plant itself is still listed in Schedule I of the Controlled Substances Act, meaning it has a high potential for abuse and no accepted medical use.
The FDA has approved several marijuana-based products, including the synthetic formulation Marinol, prescribed to treat severe appetite loss and nausea in conditions such as AIDS. This marks the first time that a drug using cannabis has been approved for use in the USA, which means that there may in fact be a domino effect as we move toward the course of the next few years.
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Epidiolex is created to treat two rare forms of childhood epilepsy. It's important to note that as a large pharmaceutical company, GW provides a much different play versus traditional marijuana companies.
The approval only covers use of the liquid drug for Lennox-Gastaut syndrome and Dravet syndrome. The first is Dravet syndrome, which is a rare genetic dysfunction that starts within a child's first year, and the second is Lennox-Gastaut syndrome, which is a form of epilepsy that causes multiple types of seizures usually starting from 3 to 5 years old. For instance, a clinical trial is underway to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder.
"Clinical development for these rare and severe conditions is essential, and today's news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures". The approval is expected to spur additional research into cannabis, which is still illegal under federal law.
"This is an important medical advance". Alan also expects that there will be more CBD products and other medications derived from cannabinoids on the market. Moreover, this is a purified form of CBD. "It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits", Gottlieb said.
"I'm really happy we have a product that will be much cleaner and one that I know what it is", Ellaine Wirrell, director of the Mayo Clinic's program for childhood epilepsy, tells the AP "In the artisanal products there's often a huge variation in doses from bottle to bottle depending on where you get it".
Epidiolex will be marketed by Greenwich Biosciences, a subsidiary of GW Pharmaceuticals.