Wasan Tita/iStock via Getty Images A phase 3 trial of Jazz Pharmaceuticals' ( NASDAQ: JAZZ ) Epidyolex (cannabidiol) failed in a Japanese study examining the drug to treat seizures associated with several conditions in pediatric patients. The primary efficacy endpoint was a pre-specified percentage change in indication-associated seizure frequency during the treatment period of up to 16 weeks. The company noted that Epidyolex's efficacy has been demonstrated in five other phase 3 trials of more than 900 patients.
Jazz said it would discuss with Japanese regulators about a potential new drug application for Epidyolex. Epidyolex is approved in the U.S.
and EU (known as Epidiolex in the U.S.) for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex.
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