Jazz’s cannabidiol therapy fails to meet endpoints in Japanese Phase III trial

Jazz Pharmaceuticals faced a setback in Japan as a Phase III trial for its cannabidiol therapy did not meet its primary endpoint. The study aimed to assess the oral cannabidiol solution as an adjunct treatment for seizures related to Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in pediatric patients. The trial did not achieve the targeted reduction in seizure frequency during the 16-week period compared to baseline.

Jazz’s cannabidiol therapy, known as Epidiolex in the U.S. and Epidyolex in the EU, was acquired through the 2021 purchase of GW Pharmaceuticals. The FDA has approved it for treating seizures in pediatric patients with LGS, DS, and TSC. Despite generating around $845.5 million in sales last year, with expectations to reach $1.3 billion by 2030, Jazz plans to persist with development in Japan. Although the primary endpoint was missed, some numeric improvements were noted in secondary endpoints.