Phase III study of Epidiolex to treat Lennox-Gastaut syndrome is published in The Lancet.-GW Pharma

GW Pharmaceuticals plc along with its U.S. subsidiary Greenwich Biosciences, announced that The Lancet has published results from a Phase III study of Epidiolex (cannabidiol) in patients with Lennox-Gastaut syndrome (LGS). Epidiolex, GW's lead product candidate and the potential first in a new category of anti-epileptic drugs (AEDs), is a pharmaceutical formulation of purified cannabidiol (CBD), a cannabinoid lacking euphoric side effects, which is being studied for the treatment of a number of rare, severe pediatric-onset epilepsy disorders.

In this study, Epidiolex significantly reduced monthly drop seizure frequency compared to placebo in highly treatment-resistant patients when added to existing treatment. Treatment with Epidiolex was generally well tolerated, with a safety profile consistent with prior reported experience. A New Drug Application (NDA) submission to the FDA for Epidiolex in the treatment of LGS and Dravet syndrome (another rare childhood-onset epilepsy) was accepted in December with an assigned PDUFA goal date of June 27th 2018 and, if approved, the medicine is expected to be available in the U.S. by prescription in the second half of 2018. A Marketing Authorisation Application (MAA) was submitted to the European Medicines Agency (EMA) in December 2017, with an expected decision in early 2019.

See-Thiele EA, Marsh ED, French JA, et al. "Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomized, double-blind placebo-controlled phase 3 trial". Published online January 24, 2018 http://dx.doi.org/10.1016/S0140-6736(18)30136-3..