The Only FDA-Approved CBD Treatment For Severe Epilepsy Completes Key Phase 3 Trial In Japan Despite Missed Primary Goal
The Only FDA-Approved CBD Treatment For Severe Epilepsy Completes Key Phase 3 Trial In Japan Despite Missed Primary Goal
Jazz Pharmaceuticals (NASDAQ:JAZZ) reported results from a Phase 3 trial in Japan evaluating the safety and efficacy of cannabidiol oral solution, Epidiolex, for treating seizures in children with rare forms of epilepsy, such as Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex.
爵士制药 (NASDAQ:JAZZ) 报告了一项在日本进行的第三阶段试验的结果，评估了大麻二酚口服溶液Epidiolex在治疗罕见的癫痫症状，如Lennox-Gastaut综合征、Dravet综合征和结节硬化症的儿童中的安全性和疗效。
While the trial did not achieve its primary goal of a significant reduction in seizure frequency, there were numeric improvements in other areas. Importantly, no new safety issues were found.
尽管该试验未能实现主要目标——显著减少癫痫发作的频率，但在其他方面数字上有改善。重要的是，未发现任何新的安全问题。
"We are confident in the overall clinical profile ofEpidiolex, which has been established in five Phase 3 clinical trials in more than 900 patients," stated Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "We believe the totality of the Epidiolexglobal data, including the findings from this trial, supports advancement of the program in Japan. 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."
"我们对Epidiolex整体临床资料的优点有信心，这一优点已在超过900名患者参与的5项第三阶段临床试验中得到确认。" Jazz Pharmaceuticals全球研发部执行副总裁Rob Iannone万.D.万.S.C.E.表示。"我们相信Epidiolex的全部全球数据，包括这项试验的结果，支持在日本推进该项目。我们正在继续收集日本患者的数据，并计划与日本监管机构就潜在新药申请（JNDA）进行沟通。我们认识到在日本罕见癫痫症患者中存在重大的未满足需求，并感谢参与该试验的研究人员、患者和护理人员。"
Read Also: Time Is Still The Enemy, Says Mom Who Moved Mountains For Her Epileptic Daughter & Still Advocates For Millions Of CBD Users
请阅读：为她患癫痫的女儿移山倒海并为数百万CBD用户发声的妈妈表示，时间仍然是敌人
Epidiolex is the only FDA-approved prescription CBD treatment for severe forms of epilepsy. It was developed and produced by GW Pharmaceuticals, which was acquired by Jazz Pharmaceuticals in 2021. Epidiolex was first approved for treating seizures connected to Lennox-Gastaut syndrome and Dravet syndrome. In 2022, Epidiolex was approved for treating seizures related to tuberous sclerosis complex.
Epidiolex是唯一获得FDA批准用于治疗严重癫痫的处方用CBD疗法。它由GW制药公司开发和生产，该公司在2021年被Jazz Pharmaceuticals收购。Epidiolex最初获得了用于治疗与Lennox-Gastaut综合征和Dravet综合征相关的癫痫发作的批准。在2022年，Epidiolex获得了治疗与结节硬化症相关的癫痫发作的批准。
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The trial is focused on measuring how much the seizure frequency changes over a treatment period of up to 16 weeks in 62 children aged 1 to 18 years old. The trial is still ongoing to gather more data on how well the treatment works and its safety for both children and adults in Japan.
该试验的重点是衡量治疗期长达16周对62名年龄为1至18岁的儿童癫痫发作频率的变化。该试验仍在进行中，以收集有关该治疗的工作效果以及儿童和成人的安全性的更多数据。
Price Action
股价变动
Jazz Pharmaceuticals' shares are trading down 4.36% on Friday morning, at $109.55 per share.
爵士制药的股票在周五上午交易下跌了4.36%，每股109.55美元。
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