Today, GW Pharmaceuticals and its subsidiary Greenwich Biosciences, a biopharmaceutical company focused on discovering, developing and promoting therapeutic cannabis-based new drugs, announced that the US FDA’s Peripheral and Central Nervous System Drug Advisory Committee unanimously supports the approval of on-going research on cannabidiol oral solutions ( A New Drug Application (NDA) for CBD, trade name Epidiolex®, for the adjuvant treatment of Lennox-Gastaut syndrome (LGS) and Dravet syndrome-associated seizures in patients aged 2 and over. If approved, Epidiolex will be the first CBD-based drug formulation and will be the first new antiepileptic drug (AED). The target date for the FDA to complete the NDA review is June 27, 2018.
LGS and Dravet syndrome usually begin to develop during childhood and is a severely destructive form of seizures. Not only is the morbidity and mortality rate high, but it also imposes a significant burden on families and caregivers. More than 90% of patients with LGS or Dravet’s syndrome have epileptic seizures many times a day, which keeps them at constant risk of falls and injuries. Physicians who treat patients with LGS and Dravet’s syndrome seek to use the currently available treatments to reduce the number of dangerous seizures. If Epidiolex is approved, it will be the first approved drug for Dravet syndrome patients.
Epidiolex, a major cannabinoid candidate drug of GW, is a pharmaceutical preparation for the purification of CBD for the treatment of several rare childhood epileptic seizures. Up to now, Epidiolex has obtained FDA orphan drug status for the treatment of Dravet syndrome, LGS, tuberous sclerosis syndrome (TSC) and infantile spasm (IS). In addition, the drug is also eligible for FDA-approved Fast Track for the treatment of Dravet syndrome.
The GW demonstrated strong clinical development projects including three randomized phase 3 clinical trials and an open-label extension study. In the Phase 3 study, Epidiolex combined with other antiepileptic treatments significantly reduced seizure frequency in patients with LGS and Dravet syndrome. In addition, Epidiolex is generally well tolerated, with most adverse events reported as mild or moderate and controllable.
▲ GW Pharmaceuticals R&D pipeline
One of the principal investigators, Dr. Elizabeth Thiele, director of pediatric epilepsy at Massachusetts General Hospital and professor of neurology at Harvard Medical School, said: “As a doctor treating LGS and Dravet syndrome, I know that patients and their families often face difficulties in using existing treatments. The major difficulties in controlling seizures, the results of these studies indicate that this drug formulation of CBD may provide new treatment options, which may be effective for some patients.”
“We are pleased that the Advisory Committee unanimously recommended approval of Epidiolex, which will provide important treatment options for patients with LGS and Dravet syndrome, two forms of the most severe and refractory epilepsy,” said Mr. Justin Gover, CEO of GW: “This favorable result marks an important milestone in our company’s unwavering commitment to address the unmet needs of patients with LGS and Drave’s syndrome, and our determination to study Epidiolex under the highest research and manufacturing standards. We look forward to working at Epidiolex. The FDA continued its discussions during the NDA review process.”
We hope that the market for this drug will go smoothly and bring hope to epilepsy patients and families as soon as possible.