Reposted from Keller and Heckman’s Blog, The Daily Intake
- As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marijuana.” As a result, while marijuana remains a Schedule I drug, hemp is no longer a controlled substance under Federal law. However, since CBD has been approved for use in the drug Epidiolex, the Federal Food, Drug, and Cosmetic Act (FD&C Act) has prohibited adding it to a food or a dietary supplement. Epidiolex is a liquid formulation of pure plant-derived CBD.
- GW Pharmaceuticals PLC, the manufacturer of Epidiolex, recently submitted a supplemental New Drug Application (sNDA) to expand the label of its Epidiolex cannabidiol oral solution, CV, to include the treatment of seizures associated with Tuberous Sclerosis Complex (TSC). Epidiolex is currently approved in the U.S. for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome. The submission is supported by data from a favorable Phase 3 safety and efficacy study conducted in 2019, which showed that Epidiolex reduced TSC-associated seizures by roughly 48% from baseline. The Phase 3 study also demonstrated that the observed safety profile was consistent with data from prior studies.
- TSC is a rare genetic disorder that causes predominantly benign tumors to grow in various vital body organs such as the brain, heart, kidneys, and lungs. Affecting more than 40,000 people in the U.S. and nearly one million people around the world, TSC is a leading cause of genetic epilepsy today. More than 60% of individuals with TSC are not able to achieve seizure control via standard methods and treatments. The disorder typically manifests in the first year of life and is linked to an increased risk of autism and intellectual disability in children.
- Epidiolex has been granted Orphan Drug Designation from FDA for the treatment of TSC. According to GW Pharmaceuticals, FDA approval of the sNDA is expected later this year. Epidiolex is GW’s lead cannabinoid product candidate and the first FDA-approved drug that contains a purified drug substance derived from marijuana.