Epidiolex has previously obtained US FDA Fast Track status for the same indication and orphan designations in both Dravet syndrome and Lennox-Gastaut syndrome (LGS).
The company now plans to launch a full clinical development programme for Epidiolex to treat Dravet syndrome and LGS. The first Phase II/III study is set to start shortly.
According to recent GW findings from open-label, "expanded access" trials, children and young adults with Dravet syndrome experienced a median overall decrease of 51%-72% in convulsive seizure frequency across various time points and analyses. The most frequent side effects included somnolence and fatigue.
Epidiolex is an oral liquid formulation of a highly purified extract of plant-derived cannabidiol, a non-psychoactive molecule from the cannabis plant.
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