UCB’s once-daily transdermal patch Neupro (rotigotine) offers sustained improvements in symptoms of Restless Legs Syndrome (RLS) over a five-year period, with nearly 40% of patients remaining symptom-free, new clinical data indicate.

Neupro is available for the symptomatic treatment of moderate to severe adult idiopathic RLS in Europe but not in the US, where the product remains in limbo for its approved indication (signs and symptoms of early-stage idiopathic Parkinson’s disease) following an April 2008 recall due to crystallisation problems. The European Commission lifted the related treatment restrictions on Neupro in June 2009.

The long-term RLS data were presented at the 62nd American Academy of Neurology annual meeting in Toronto, Canada. They represent the longest ever open-label prospective follow-up of a placebo-controlled Phase II trial in RLS, UCB noted.

Of the 295 patients with moderate to severe RLS who entered the study, 126 or 43% completed the five-year follow-up. The mean dose of rotigotine was 2.43mg every 24 hours after initial titration and 3.09mg/24 hours at the end of the trial.

Of the patients who stayed the course, 59% were classed as remitters – scoring less than or equal to 10 on the International Restless Legs Syndrome Study Group Rating Scale (IRLS) – and 39% as symptom-free (IRLS = 0).

The total IRLS score ranges from 0 (no symptoms) to 40 (very severe symptoms), with a score of over 20 indicating severe RLS. In the follow-up data presented in Toronto, the mean IRLS score was 27.8 at baseline, improving to 9.0 by the end of the study. Sustained improvements were also seen in quality of life and other RLS rating scores, UCB reported. Among the patients who dropped out of the trial, 30% did so due to adverse events.

A comparison of one-, two- and five-year efficacy data (from 220, 191 and 126 patients respectively) showed that improvements in RLS remained stable throughout the follow-up period, with IRLS scores of 17.4 points at one year, 17.2 at two years and 18.7 at five years.

UCB says it continues to work with the Food and Drug Administration in the US, where a supplemental New Drug Application for RLS was accepted for filing in December 2007, so that “Neupro can be available to patients with early-stage Parkinson’s disease as soon as possible”.

According to the company, some researchers estimate that RLS affects as many as 12 million Americans, while the actual occurrence may be much higher as the condition is thought to be under-diagnosed and, in some cases, mis-diagnosed.