GSK withdraws Solzira NDA, will reformat data
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GlaxoSmithKline will reformat data from a trial of its gabapentin prodrug Solzira and resubmit the NDA as quickly as possible, the company says Nov. 10. GSK and partner XenoPort withdrew the NDA after FDA requested a reformatted presentation of data from the study for patients with restless legs syndrome. A 327-patient Phase III trial found a statistically significantly lower proportion of relapses in the treatment group (9 percent) versus the placebo group (23 percent) (1Pharmaceutical Approvals Monthly January 2008, p. 20). The drug would be the first non-dopaminergic agent for the treatment of RLS and would offer potential advantages over GSK's RLS drug Requip