UCB said the European Medicines Agency (EMEA) accepted application for marketing authorisation for the use of Neupro in the treatment of moderate-to-severe Restless Legs Syndrome (RLS).
Neupro is a once-daily patch designed to provide continuous drug delivery over a 24 hour period. Restless Legs Syndrome is a chronic neurological disorder that affects between three and ten per cent of the population.
"This new filing for Neupro reflects UCB's commitment to finding innovative medicines for conditions where there is a continuing need for alternative treatment," commented Troy Cox, president-CNS Operations, UCB.
The filing is based on the results of two fixed-dose, randomised, double-blind, placebo-controlled efficacy and safety studies that evaluated rotigotine for the treatment of moderate-to-severe idiopathic RLS in approximately 1,000 patients over six months. In these trials, rotigotine produced statistically significant reductions in RLS symptoms compared to placebo and was generally well-tolerated. The efficacy of rotigotine was evaluated by monitoring the International Restless Legs Severity Scale (IRLS), a clinician-administered tool considered to be the best scale for evaluating the severity and frequency of RLS symptoms and the degree to which they affect sleep and daily life. The most frequently reported adverse events associated with rotigotine in these studies were application site reactions, nausea, dizziness, somnolence and headache.
Neupro is already approved in Europe and the US for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's Disease as monotherapy, and in Europe as adjunctive therapy with levodopa for advanced-stage Parkinson's disease.
Restless legs syndrome (RLS) is a chronic neurological disorder that affects between 3 and 10 per cent of the population. It is characterized by unpleasant feelings in the legs and an irresistible urge to move in order to relieve the discomfort. RLS sensations are frequently described as tingling, burning, tugging, gnawing and pulling. The exact cause of RLS is not known; however, recent clinical research has linked certain genes to RLS, suggesting that the disorder is biologically based.
Symptoms of RLS typically appear during periods of rest and inactivity, particularly in the evenings and at night. This can make it difficult to fall asleep and stay asleep, thus preventing recuperative sleep and often leading to daytime fatigue and reduced alertness. While RLS symptoms are generally most pronounced in the evening and while at rest, other periods of inactivity, such as long flights, car trips and sitting in a theatre or cinema, can also trigger symptoms.
In Europe, Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy and in combination with levodopa for advanced stage Parkinson's disease.
Neupro delivers the dopamine agonist, rotigotine, directly from a patch into the bloodstream, through the skin. Rotigotine is a drug that mimics dopamine, a chemical messenger that transmits impulses between nerve cells in the brain to produce smooth, coordinated movement. Neupro offers once-daily dosing and a good tolerability profile.
UCB, Brussels, Belgium is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing more than 10,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis.