GW Phar­ma de­tails an im­pres­sive PhI­II case for a cannabis-based drug for se­vere epilep­sy as it preps an NDA

GW Phar­ma­ceu­ti­cals lined up a straight shot at a key ap­proval for Epid­i­olex to­day, pub­lish­ing its im­pres­sive Phase III da­ta for a se­vere form of child­hood epilep­sy which in­spired a block­buster fore­cast for the cannabis-based ther­a­py.

GW an­nounced last spring that Epid­i­olex — a liq­uid ther­a­py us­ing pu­ri­fied cannaba­di­ol — trig­gered a mean re­duc­tion in con­vul­sive seizures of 39% among treat­ment-re­sis­tant pa­tients with Dravet syn­drome, com­pared to on­ly 13% among the place­bo group. A re­port pub­lished in The New Eng­land Jour­nal of Med­i­cine adds to­day that 43% of the drug group had a mean drop of 50% or more — com­pared to 27% in the place­bo group. And 5% stopped hav­ing seizures, with none in the place­bo arm do­ing as well.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.