Epidiolex Approved to Treat TSC-Related Seizures

It’s no secret that cannabis and its components are highly controversial. However, cannabis has been used to treat a variety of conditions, including seizures. According to Candid Chronicle, another related treatment was recently FDA-approved. GW Pharmaceuticals and Greenwich Biosciences, Inc. shared that Epidiolex (cannabidiol oral solution), approved as Epydiolex in the European Union (EU), received FDA approval for the treatment of Tuberous Sclerosis Complex (TSC)-associated seizures. 

Epidiolex

So what exactly is Epidiolex? According to the Epidiolex website, this treatment, given in an oral solution, is:

The first and only FDA-approved prescription CBD used to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients 1 year of age and older.

That’s right, Epidiolex is also approved for the treatment of LGS and Dravet syndrome, and has been for the last 3 years or so. However, the most recent approval changed the age range to those listed above.

Additionally, the Epidiolex website shares that the treatment reduced TSC seizures by a mean of 48% over a 16-week treatment period. At the same time, 5% of patients achieved total freedom from TSC-associated seizures. While Epidiolex is relatively safe and well-tolerated, some side effects may occur, including increased liver enzymes, nausea and vomiting, fatigue, diarrhea, appetite loss, and general malaise. 

Because Epidiolex is already available for patients with LGS and Dravet syndrome, those with TSC-associated seizures should be able to gain immediate medication access.

Tuberous Sclerosis Complex (TSC)

TSC1 or TSC2 gene mutations cause tuberous sclerosis complex (TSC), a rare genetic disease. Normally, these genes manage cell growth and control proliferation. However, these mutations allow cells to grow out of control, causing benign (non-cancerous) tumors to form throughout the body. In many cases, symptoms appear in infancy or childhood. These include:

  • Benign tumors or lesions on the brain, heart, lungs, skin, or kidneys
  • Seizures
    • In fact, an estimated 85% of those with TSC experience treatment-averse seizures, meaning treatments often do not work.
  • Developmental delays
  • Skin abnormalities, including:
    • Light-colored skin patches
    • Thickened skin
    • Growths under/around nails
  • Heart, kidney, and lung function problems
  • Breathlessness
  • Anemia (low red blood cell count)
  • Hyperactivity, irritability, or aggression
  • Repetitive behaviors
Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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