’ efforts to get its cannabidiol therapy approved in Japan have hit a snag after a Phase III trial in Japan evaluating the therapy failed to meet its primary endpoint. The Phase III study evaluated the cannabidiol oral solution as an adjunct treatment for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in paediatric patients. The study failed to achieve its primary endpoint of a pre-specified percentage change in indication-associated seizure frequency during the 16-week treatment period compared to baseline.
Jazz’s is marketed as and . It is a plant-based cannabis-based medicine. The company added the therapy to its portfolio as part of the 2021 acquisition of .
The US Food and Drug Administration (FDA) has approved the therapy for treating seizures associated with paediatric patients with three rare epileptic disorders, namely Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. Epidiolex/Epidyolex is a high revenue-generating drug for Jazz. It raked in about $845.
5m in sales last year, as per Jazz’s financials. GlobalData expects the therapy sales to continue their upward trajectory and pull in over $1.3bn by 2030.
GlobalData is the parent company of . Despite the Phase III setback, Jazz plans to continue the therapy’s development in Japan. The company’s executive vice president, Rob Iannone said: “We are confident in the overall clinical profile of Epidyolex, which has been e.