Jazz Pharma: Phase 3 Trial Of Epidiolex For Rare Epilepsies Fails To Meet Primary Endpoint

(RTTNews) - Jazz Pharmaceuticals plc (JAZZ), in an update on Cannabidiol Oral Solution Phase 3 Trial in Japan in Treatment-Resistant Epilepsies, said that 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.

The Phase 3 open-label, single-arm clinical trial investigated the safety and efficacy of cannabidiol oral solution (marketed as Epidiolex/Epidyolex globally) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in Japanese pediatric patients.

"We are continuing to collect data in Japanese patients and plan to engage with regulatory authorities in Japan regarding a potential new drug application (JNDA). We recognize the significant unmet need for patients in Japan living with rare epilepsies and thank the investigators, patients and caregivers who are involved in this trial," said Rob Iannone, executive vice president, global head of research and development of Jazz Pharmaceuticals.

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