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EMA grants orphan status to GW Pharmaceuticals' Epidiolex for Dravet syndrome
22 October 2014 - 22 October 2014 - UK cannabinoid prescription drug maker GW Pharmaceuticals plc (NASDAQ:GWPH; LON:GWP) said Wednesday that Epidiolex (cannabidiol or CBD), its investigational cannabidiol product, had received orphan status from the European Medicines Agency (EMA) as a therapy of Dravet syndrome, a rare and treatment-resistant form of childhood epilepsy.

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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