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Stellar Zogenix Phase III Epilepsy Data Lift ZX008's Competitive Position

 
• By Emily Hayes

Company is planning to file in the second half with two pivotal studies, but says it is "worth exploring" with the US FDA whether data from the first study could support an application.

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Impressive results from Zogenix Inc.'s first Phase III study of ZX008 (low-dose fenfluramine) in the life-threatening epilepsy condition Dravet syndrome are holding up well so far in comparison to the leading drug in the development space – GW Pharmaceuticals PLC 's Epidolex (cannabidiol, or CBD) – and may support an earlier filing than expected.

In a top-line release on Sept. 29 from Study 1, the first of two pivotal trials to report, Zogenix reported strikingly positive data for the drug as an add-on treatment...

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