Epidiolex(大麻二酚)[CBD]口服液获FDA批准，用于治疗两种罕见而严重的癫痫发作——Lennox-Gastaut综合征和Dravet综合征。这是FDA批准的第一种含有从大麻中提取的纯化药物的药物。这也是FDA首次批准用于治疗Dravet综合征的药物。

2018年11月2日，GW Pharmaceuticals公司宣布，美国推出新型抗癫痫药物Epidiolex（cannabidiol，大麻二醇）口服液体制，该药于适用于2岁及以上患者，治疗与Lennox-Gastaut综合征（LGS）和Dravet综合征（DS）相关的癫痫。Epidiolex于今年6月25日获得美国FDA批准，成为首个高纯度、植物源性大麻二醇（CBD）处方药物制剂，同时也是首个新一类别的新型抗癫痫药物（AED）。
  LGS和DS是2种罕见的、严重的、儿童期发病的癫痫，也是最难以治疗的癫痫类型。Epidiolex是一种口服的、高纯度CBD提取物液体制剂，CBD是一种来自大麻植物的非精神类成分，对于神经系统具有多种药理作用。大量的研究表明，CBD具有明显的抗癫痫和抗惊厥活性，相比现有抗癫痫药物副作用更少。
  之前Epidiolex一直没有上市是因为美国管制（特殊）药品监督管理局（DEA）将Epidiolex列为了1类管制药物。不过就在9月底，DEA将Epidiolex从1类管制转入了5类管制药物。
  DEA是美国司法部联邦调查局（FBI）的下属单位，是负责对麻醉药等特殊药物进行强制管理的一个联邦机构。在美国，麻醉药和精神药品属于管制药物，根据其滥用潜在风险的大小以及可能危害健康的程度分为5类（1-5），其中：第一类管制药物具有高度滥用性，目前未被认可临床使用、缺乏认可的安全性，限制性最高；第5类则是限制性最低的分类，归入第5类的药物已经证明了医疗用途和低的滥用潜力，例如常用的止咳制剂Robitussin AC（含有愈创甘油醚和可待因）以及一些常用的处方抗癫痫药如Vimpat（拉科酰胺）、Briviact（布瓦西坦）和Lyrica（普瑞巴林）。
  GW公司首席执行官Justin Gover表示，我们非常高兴的宣布，现在美国的医师可以处方Epidiolex作为LGS和DS综合征患者的新治疗选择，这是2类最难以治疗的儿科癫痫发作类型，对现有的抗癫痫药治疗没有反应，该领域对安全有效的新药存在着迫切的医疗需求。

  完整处方资料附件：https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf

Epidiolex Now Available to Treat Seizures Associated With LGS, Dravet Syndrome
Epidiolex (cannabidiol oral solution) has been made available by GW Pharmaceuticals for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients ≥2 years old.
The Food and Drug Administration (FDA) approved the treatment in June 2018, making it the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol, as well as the first treatment indicated for patients with Dravet syndrome. The approval of Epidiolex was based on data from 3 randomized, double-blind, placebo-controlled trials involving patients with either LGS or Dravet syndrome. In September 2018, Epidiolex was rescheduled from a Schedule I substance to a Schedule V, the lowest restriction classification.
Epidiolex is supplied as a 100mg/mL strawberry-flavored oral solution. The product is packaged with a calibrated measuring device and is recommended to measure and deliver the prescribed dose. Any unused portion of the medication should be discarded after 12 weeks of first opening the bottle.
Prior to starting treatment, patient serum transaminases (ALT and AST) and total bilirubin levels should be obtained because of the risk of hepatocellular injury. Food may affect levels of Epidiolex, therefore patients should be advised to take the drug consistently either in the fasted or fed state.
GW Pharmaceuticals has also launched the Epidiolex Engage support program to help patients and clinicians navigate the steps to obtaining Epidiolex; the program also provides education and resources to patients and caregivers.
“We are delighted to announce that Epidiolex is now available by physician prescription as a new treatment option for patients with LGS and Dravet syndrome, two of the most difficult-to-treat forms of childhood-onset epilepsy,” said Justin Gover, Chief Executive Officer of GW Pharmaceuticals. “We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.”