UCB announces positive top-line results from two phase 3 studies of Neupro to treat Parkinson’s disease

Brussels, Belgium Saturday, February 07, 2015, 10:00 Hrs  [IST]

UCB announced positive top-line results from two phase 3 studies evaluating Neupro (rotigotine transdermal patch) in the treatment of patients in China with early- and advanced-stage idiopathic Parkinson’s disease. Results from the phase 3 study in patients with early-stage Parkinson’s disease demonstrated that rotigotine transdermal patch significantly improved symptoms when compared to placebo. In addition, data from the phase 3 study in advanced Parkinson’s disease showed that patients treated with rotigotine had a significantly greater decrease in their ‘off’ time, or periods of poor mobility, slowness and stiffness, compared to those patients taking placebo. The adverse event profile observed in these studies and in this Chinese population were consistent with that known for rotigotine. Based on the positive results UCB intends to submit a regulatory application in China in 2015 for Neupro in the treatment of early- and advanced-stage Parkinson’s disease. “Parkinson’s disease is a chronic and progressive neurological disease that can significantly impact patients’ lives. The positive results from the two Phase 3 studies in China evaluating Neupro in Parkinson’s disease is a significant milestone to making Neupro available to more patients and healthcare professionals worldwide. Subject to regulatory approval, we hope to deliver Neupro in China as a new treatment option to patients with early- and advanced-stage Parkinson’s disease,” says Professor Dr. Iris Loew-Friedrich, chief medical officer and executive vice president, UCB. One of the two phase 3 studies was a  multicentre, randomised, double-blind, parallel-group, placebo-controlled, 24-week study that evaluated the efficacy and safety of rotigotine (escalating weekly dose starting with daily doses of 2 mg/24 hours to 8 mg/24 hours) in 247 adult patients (30 years and older) with early-stage idiopathic Parkinson’s disease. The primary efficacy variable was the change in the sum of the score from the Activities of Daily Living scale and motor examination in the Unified Parkinson's Disease Rating Scale (UPDRS) from baseline to the end of the maintenance period. The second phase 3 study was a multicenter, randomized, double-blind, parallel-group, placebo-controlled, 12-week study that evaluated the efficacy and safety of rotigotine (escalating weekly dose starting with daily doses of 4 mg/24 hours to 16 mg/24 hours) in 346 adult patients (30 years and older) with advanced-stage idiopathic Parkinson’s disease who were not well-controlled on levodopa. The primary efficacy variable was the change in absolute time spent "off" from baseline to the end of the double-blind maintenance period. Results from these studies will be presented at upcoming international congresses. Today, Neupro, a transdermal patch,  is currently available as a treatment for Parkinson’s disease in over 46 countries worldwide, including the US, the European Union and Japan. Neupro is currently not approved in China for the treatment of Parkinson’s disease.  Parkinson's disease is a progressive and chronic neurological disease characterised by the physical motor symptoms of resting tremor, muscle rigidity and slowness of movement. Symptoms not related to movement (non-motor symptoms) can also occur and include pain, sleep disturbances and depression.  It is estimated that 6.3 million people are living with Parkinson’s disease worldwide. The age of onset is usually over 60 years. Although it is estimated that 1 in 10 people are diagnosed before the age of 50. Neupro (rotigotine) is approved in the European Union for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease, as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. 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 occur (end of dose or on-off fluctuations). Neupro® is also approved in the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults. Neupro (rotigotine) is approved in the European Union for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease, as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8500 people in approximately 40 countries, the company generated revenue of € 3.4 billion in 2013.

http://health.einnews.com/article/248621659/g_XwdqLF8QXEtgzk