A pharmaceutical formulation of purified cannabidiol (CBD), a cannabinoid without euphoric side effects, is expected to launch in the second half of this year.
The New Drug Application for Epidiolex (GW Pharmaceuticals) was accepted in December by FDA for 2 rare forms of epilepsy, and the agency assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 27 for Epidiolex. “If approved, the medicine is expected to be available in the US by prescription in the second half of 2018,” GW Pharmaceuticals said in a statement.
Additionally, Epidiolex showed a reduced monthly drop in seizure frequency compared to placebo in highly treatment-resistant patients with Lennox-Gastaut syndrome (LGS), a rare, lifelong form of epilepsy, according to a new study published in The Lancet.
Over a 14-week treatment period, 44% of patients taking Epidiolex saw a significant reduction in seizures, compared with 22% of the placebo group.
“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, CEO of GW Pharmaceuticals, in the statement. “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,” Gover added.