04:48 PM EDT, 08/22/2024 (MT Newswires) -- Jazz Pharmaceuticals ( JAZZ ) said Thursday a phase 3 trial in Japan of a cannabidiol oral solution for treatment-resistant epilepsies didn't meet the primary efficacy objective.
"The trial did not meet the primary efficacy endpoint of a pre-specified percentage change in indication-associated seizure frequency during the treatment period (up to 16 weeks) compared to baseline in Japanese pediatric patients," the company said.
The company observed numeric improvements in the primary and several secondary endpoints.
"We believe the totality of the Epidyolex global data, including the findings from this trial, supports advancement of the program in Japan," said Rob Iannone, global head of research and development of Jazz.
The phase 3 trial in Japan is assessing the safety and efficacy of the cannabidiol oral solution to treat seizures linked to Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex, Jazz said, adding the solution is marketed as Epidiolex/Epidyolex globally.