Neupro(R), The Only Transdermal Patch For Restless Legs Syndrome, Now Available In The UK

Main Category: Neurology / Neuroscience
Article Date: 02 Jul 2009 - 1:00 PDT

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The only transdermal patch in the UK for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults was launched by UCB. Applied once-a-day, Neupro® (rotigotine transdermal patch) allows for continuous drug delivery to provide stable drug levels in the bloodstream 24 hours a day and improves symptom control day and night.

RLS may present itself as a 24 hour condition with symptoms frequently occurring during periods of rest, such as during sleep, or inactivity during the day, like long car journeys.RLS is thought to affect between three and 10 per cent of the population to some extent, causing sensations such as tingling or prickling sensations, burning, tugging and creeping. If left untreated, in some patients RLS can cause exhaustion and negatively impact quality of life.

The goal of treatment for idiopathic RLS is symptom remission. Clinical trials, evaluating the efficacy and safety of rotigotine over a six month period in almost 1000 patients with RLS showed significant and clinically relevant improvements in RLS symptoms compared with placebo and that the treatment was generally well tolerated. 'The most common adverse drug reactions reported in RLS patients treated with rotigotine were nausea, application site reactions, fatigue and headache.

"The symptoms of Restless Legs Syndrome can have a significant impact on quality of life for many people, often affecting sleep, job performance and social activities. People with severe symptoms may require lifelong treatment," said Professor Ray Chaudhuri, Consultant Neurologist, University College Hospital. "The clinical trial data show that rotigotine provides us with a new and effective option for tackling this debilitating condition."

Supporting Clinical Data

In a clinical trial of 458 patients with moderate to severe RLS, rotigotine (1mg/24h, 2mg/24h and 3mg/24h) proved more efficacious than placebo in relieving symptoms in patients over a six month treatment period. The primary efficacy outcomes were the absolute change from baseline to the end of six month maintenance period in IRLS sum scores and in the clinical global impressions (CGI) item 1 score.

Efficacy analyses were done on 112 patients in the 1 mg group, 109 in the 2 mg group, 112 in the 3 mg group, and 114 in the placebo group. Mean change in IRLS sum score from baseline at the end of the maintenance phase was -13∙7 (SE 0∙9) in the 1 mg group, -16∙2 (0∙9) in the 2 mg group, -16∙8 (0∙9) in the 3 mg group, and -8∙6 (0∙9) in the placebo group (p<0•0001 for treatment difference vs placebo with each dose). Mean change in CGI item 1 score from baseline at the end of the maintenance phase was -2∙09 (0∙14) in the 1 mg group, -2∙41 (0∙14) in the 2 mg group, -2∙55 (0∙14) in the 3 mg group, and -1∙34 (0∙14) in the placebo group (p<0•0001 for treatment difference vs placebo with each dose).

IRLS Scale

The International Restless Legs Syndrome Study Group Rating Scale (IRLS) is a ten-item scale developed and validated by The International Restless Legs Syndrome Study Group and considered to be a useful scale for evaluating the severity and frequency of RLS symptoms and the degree to which they affect sleep and daily life. It is administered by clinicians and includes questions related to the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence and impact of RLS on activities of daily living and mood. The total IRLS score ranges from 0 (no symptoms) to 40 (very severe symptoms). A score of >20 indicates severe RLS.

CGI Scale

The Clinical Global Impressions (CGI) scale is a well-established tool which measures the general severity of an illness, clinical improvement or efficacy of treatment parameters. It is widely used in clinical research and clinical trials across various therapeutic areas and assesses response to treatment on a patient's overall condition.

About Neupro® in Europe

The launch of Neupro® follows the granting of a European licence for the symptomatic treatment of moderate to severe idiopathic RLS in adults in September 2008. Neupro® is approved in Europe for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults, and for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease, as monotherapy or in combination with levodopa over the course of the disease through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occurs.

Source
UCB