GSK reports positive results for restless leg candidate

GlaxoSmithKline (GSK) and XenoPort have reported positive top-line results for their phase III clinical trial investigating the potential of candidate XP13512 (GSK1838262) in maintaining efficacy in patients with moderate-to-severe primary restless leg syndrome (RLS).

The nine-month study showed that XP13512 was largely well-tolerated as well as demonstrating a significant increase in the number of patients who met pre-specified relapse criteria compared to placebo.

Atul Pande, senior vice-president of the GSK Neurosciences Medicines Development Centre, described the study as an “important next step” for the preparation of a New Drug Application (NDA) submission.

“XenoPort and GSK are committed to continuing research in this important area where there is still significant unmet medical need,” he added.

The primary endpoint of the trial was the proportion of RLS patients who “relapsed” or saw their symptoms worsen during the treatment period.

Ronald W Barrett, chief executive officer of XenoPort, stated that he was encouraged by the results and indicated that the firms expected NDA filing to take place later this year.

Also this week, GSK announced that its once-daily Avamys (fluticasone furoate) nasal spray has been granted marketing authorisation by the European Commission for the treatment of allergic rhinitis.