Jazz Pharmaceuticals Provides Update On Cannabidiol Oral Solution Phase 3 Trial In Japan In Treatment-Resistant Epilepsies

Author: Benzinga Newsdesk | August 22, 2024 04:11pm

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced top-line results from the Phase 3 open-label, single-arm trial in Japan evaluating the safety and efficacy of cannabidiol oral solution (marketed as Epidiolex®/Epidyolex® globally) as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC). 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; however, numeric improvements were observed in the primary and several secondary endpoints. No new safety signals were observed in the trial.

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