The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to GW Pharmaceuticals’ investigational cannabidiol (CBD) product Epidiolex for the treatment of Dravet syndrome.
How anti-epileptic cannabinoids such as Epidiolex precisely work is still a subject of intensive research, but data show that some cannabinoids can modulate neurotransmission, affect oxidative stress, and reduce neuro-inflammation. In addition, certain cannabinoids exhibit anti-convulsant effect that may prevent epileptic neuronal hyperexcitability.
The Fast Track designation expedites the development and review of drugs that aim to treat serious conditions and address an unmet medical need. Among other benefits, drug candidates that have been granted Fast Track status are given increased and more frequent access to the FDA for reviews and meetings.
GW CEO Justin Gover said, “The granting of Fast Track designation, in addition to Epidiolex having already received orphan drug designation from the FDA, represents significant additional support... With GW having already opened an Investigational New Drug (IND) for Epidiolex, we are on track to commence a Phase 2/3 clinical trial in Dravet syndrome in the second half of this year.”
Also known as Severe Myoclonic Epilepsy of Infancy (SMEI), Dravet syndrome is a rare and devastating form of epilepsy that seriously limits the life span of children it affects. The disease is characterized by seizures in the first year of life, which develop into prolonged epileptic events in the second year of life. Other seizure types typically begin to manifest as the disease progresses, putting patients with Dravet syndrome at higher risk for sudden unexplained death in epilepsy (SUDEP) and other co-morbid conditions. There is currently no cure for Dravet’s syndrome.
The company announced that it intends to conduct another clinical development program for the drug as treatment of Lennox-Gastaut syndrome (LGS). The FDA has awarded Orphan Drug designation to the drug in LGS earlier in 2014. GW said it will hold a pre-IND meeting with the agency in mid-2014 and expects to conduct two Phase III trials in LGS by next year.