The FDA has approved Epidiolex as a treatment for different types of epilepsy
After months of hard work, it appears that the efforts of a British pharmaceutical company focused on cannabis and cannabidiol (CBD) have paid off. Its drug to treat tuberous sclerosis complex (TSC) seizures has received the go-ahead from The Food and Drug Administration (FDA) and can now be considered a drug with the FDA’s seal of approval.
Epidiolex, as the drug is known, was announced as FDA-approved by Cambridge-based GW Pharmaceuticals and its US subsidiary Greenwich Biosciences, Inc. earlier this month, successfully achieving its major goal. The drug specializes in treating all symptoms related to TSC. In the European Union, the formulation was also approved under the name Epydiolex, further proof that GW Pharmaceuticals has done more than well.
Three years ago, the FDA had already approved this CBD-based drug to treat seizures related to Dravet syndrome and Lennox-Gastaut syndrome. However, the effects of this cannabis compound have now been expanded even further for the treatment of different seizures. CBD has long been tested as a treatment for difficult-to-treat epilepsy and has shown promising results. Taking CBD oil reduces seizures by half in the vast majority of people suffering from this condition, and that is why more and more research is being done for its improved discovery.
The recent approval of Epidiolex applies to TSC patients as long as they are past the first year of life. Furthermore, according to Phase 3 safety and efficacy data, 25 mg/kg per day for TSC patients is the recommended dose for this drug.