Cannabis-based prescription medicine Epidiolex is indicated for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. Credit: Don Goofy.

UK-based GW Pharmaceuticals and its US division Greenwich Biosciences have launched an oral solution of cannabis-based drug Epidiolex in the US to treat seizures in Lennox-Gastaut syndrome (LGS) or Dravet syndrome patients aged two years and above.

Epidiolex is said to be the first plant-derived cannabidiol (CBD) pharmaceutical formulation in the country. The US Food and Drug Administration (FDA) accepted the company’s new drug application (NDA) in January this year and granted approval in June.

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The regulatory agency also granted orphan drug designation for Epidiolex to treat seizures caused due to tuberous sclerosis complex (TSC).

GW is now seeking approval from the European Medicines Agency (EMA).

GW Pharmaceuticals CEO Justin Gover said: “We are delighted to announce that Epidiolex is now available by physician prescription as a new treatment option for patients with LGS and Dravet syndrome, two of the most difficult-to-treat forms of childhood-onset epilepsy.

“Epidiolex is now available as a new treatment option for patients with LGS and Dravet syndrome, two of the most difficult-to-treat forms of childhood-onset epilepsy.”

“Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures.”

The drug was evaluated in three randomised, controlled Phase III clinical trials and one open-label extension study conducted as part of the EPIDIOLEX clinical development programme.

Data showed that Epidiolex significantly minimised the drop seizures frequency in LGS patients and convulsive seizures in Dravet syndrome patients when given in combination with other antiepileptic therapies.

The most common adverse reactions associated with the drug were somnolence, decreased appetite, diarrhoea, transaminase elevations, fatigue, rash, insomnia and infections.

Currently, GW is evaluating Epidiolex in a separate Phase III clinical development programme for treating seizures associated with TSC. Greenwich Biosciences will market the drug in the US.