GSK/XenoPort withdraw Solzira filing
UK drug major GlaxoSmithKline and USA-based XenoPort say that the New Drug Application for Solzira (gabapentin enacarbil) extended-release tablets for the treatment of moderate-to-severe primary restless legs syndrome has been withdrawn.
The US Food and Drug Administration has requested that the data in a single study be reformatted. In addition, GSK will conduct a review of other trial findings taking this input into account. The withdrawal does not relate to the content of the filing, the firms noted, adding that GSK plans "to resubmit the NDA quickly once this work is complete."
The resubmission will lead to a delay in the receipt by XenoPort of milestone payments of $23.0 million in total from GSK and the US unit of Japanese drug major Astellas, which are associated with the FDA's acceptance of the NDA.
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