NDA acceptance triggers $23M fee to XenoPort
US drug developer XenoPort says that the Food and Drug Administration has accepted for review the New Drug Application filed by its partner GlaxoSmithKline for Solzira (gabapentin enacarbil) extended-release tablets for moderate-to-severe primary restless legs syndrome.
In accordance with XenoPort's collaboration agreements with GSK and its other partner, Japanese drug major Astellas, the FDA's acceptance of the NDA triggers milestone payments to XenoPort of $23.0 million in the aggregate.
Last year, the companies withdrew the NDA after the agency requested that the data in a single study be reformatted (Marketletter November 17, 2008).
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