GlaxoSmithKline and XenoPort Inc received a Complete Response letter from the US Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant (gabapentin enacarbil) Extended-Release Tablets, an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).
A Complete Response letter 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.
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. FDA acknowledged that similar findings were known for gabapentin at the time of its approval for refractory epilepsy, but concluded that the seriousness and severity of refractory epilepsy justified the potential risks.
The companies are assessing the appropriate next steps and will be communicating with FDA.