GSK and XenoPort receive Complete Response Letter

FDA review

US-based biopharmaceutical company XenoPort, along with leading pharmaceutical company GlaxoSmithKline, received a Complete Response letter from the US Food and Drug Administration (FDA) on Wednesday regarding the New Drug Application (NDA) for Horizant (gabapentin enacarbil) Extended-Release Tablets.

The drug, an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome (RLS), had applied for an NDA on 9 January 2009, but after reviewing the application the FDA have no issued a Complete Response letter.

This notice is issued by the FDA's Center of Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form. According to reports from Wednesday, GSK and XenoPort are currently evaluating the Complete Response letter, in which the FDA indicated that a preclinical finding of pancreatic acinar cell tumors in rats was of sufficient concern to preclude approval of Horizant for RLS at this time.

Next steps

The FDA say that while it acknowledges that similar findings were known for gabapentin at the time of its approval for refractory epilepsy, it concluded that the seriousness and severity of refractory epilepsy justified the potential risks. As such, GSK and XenoPort are now looking to assess the appropriate next steps through communication with FDA.

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