EPIDYOLEX, the first and only cannabis-based medicine approved by the Therapeutic Goods Administration for the treatment of seizures associated with Lennox-Gastaut syndrome in patients aged 2 years and older, is now available on the PBS.
The PBS listing is based on positive results from two pivotal, double-blind, randomised, placebo-controlled trials.
Epidyolex, when added to other anti-seizure medicines, significantly reduced the frequency of drop seizures (atonic, tonic, and tonic-clonic seizures) compared to placebo in patients with Lennox-Gastaut syndrome.
The most common adverse reactions observed in pivotal trials were somnolence, decreased appetite, diarrhoea, pyrexia, fatigue, and vomiting.
Ingrid Scheffer, paediatric neurologist and epileptologist, at Austin Health and the University of Melbourne said, "Epidyolex is pharmaceutical-grade and the only cannabis-based medicine with demonstrated efficacy in refractory childhood epilepsies such as Lennox-Gastaut and Dravet syndromes."
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