GW Pharmaceuticals, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that The Lancet, one of the world’s oldest and best known general medical journals, has published results from a Phase 3 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 U.S. Food and Drug Administration (FDA) for Epidiolex in the treatment of LGS and Dravet syndrome (another rare childhood-onset epilepsy) was accepted in December and, if approved, the medicine is expected to be available in the USA. 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.
“Publication of this landmark study by The Lancet is an exciting achievement and marks the second time that Epidiolex data have been published in a highly prestigious journal, following last year’s publication in The New England Journal of Medicine,” said Justin Gover, GW’s Chief Executive Officer. “These publications highlight the potential of Epidiolex to address the significant unmet need in LGS and Dravet syndrome, two very challenging epilepsy conditions, and we look forward to working with the FDA and EMA as they review our marketing applications for Epidiolex. We are absolutely focused on the goal of making this important new medicine available to appropriate patients and their caregivers as quickly as possible.”
Epidiolex, GW’s lead cannabinoid product candidate is a pharmaceutical formulation of purified cannabidiol (CBD), which is in development for the treatment of several rare childhood-onset epilepsy disorders.