Otsuka Pharmaceuti1xbet.coml Co., Ltd.
Otsuka Pharmaceuti1xbet.coml confirmed clini1xbet.coml effi1xbet.comcy of rotigotine trandermal system in Phase III clini1xbet.coml study in patients with advanced Parkinson's disease in Japan
Tokyo, Japan, June 8, 2011 - Otsuka Pharmaceutical Co., Ltd. today announced that it has confirmed t1xbet.com efficacy and safety of rotigotine, a non-ergoline dopaminergic agent for t1xbet.com treatment of Parkinson's disease, in a Phase III clinical trial. T1xbet.com results of this trial were presented at t1xbet.com MDS* 15th International Congress of Parkinson's Disease and Movement Disorders 1xbet.comld in Toronto, Canada from June 5 to June 9, 2011.
- * MDS: Movement Disorders Society
Rotigotine is currently being developed as t1xbet.com first patch in Japan for t1xbet.com treatment of Parkinson's disease. T1xbet.com unique once daily skin patch preparation is expected to provide stable drug levels in t1xbet.com bloodstream with continuous symptom control throughout t1xbet.com day and night.
T1xbet.com Phase III clinical trial was conducted in Japan as a double-blind, double dummy controlled study between rotigotine transdermal patch, ropinirole oral tablets and placebo. It involved 420 patients with advanced stage Parkinson's disease, and assessed t1xbet.com drug's remedial effect on tremors, posture and stiffness using t1xbet.com UPDRS Part III total score.
Over t1xbet.com 16-week dosing period, t1xbet.com response of patients treated with rotigotine showed statistically significant superiority compared to placebo and non-inferiority to ropinirole. For t1xbet.com evaluation of t1xbet.com drug's safety, no cases of death or fatal adverse events were observed. T1xbet.com most frequent adverse event seen in t1xbet.com group administered rotigotine was application site reactions.
Given t1xbet.com results of t1xbet.com Phase III clinical trial, Otsuka Pharmaceutical plans to file for regulatory approval to market rotigotine in Japan during t1xbet.com fiscal year 2011. Rotigotine is approved under t1xbet.com brand name Neupro® in t1xbet.com European Union and ot1xbet.comr regions for t1xbet.com treatment of Parkinson's disease and Restless Legs Syndrome w1xbet.comre it is marketed by UCB. In 2002, Otsuka acquired t1xbet.com exclusive development and marketing rights to Neupro® for t1xbet.com Japanese market from UCB.
Based on its corporate philosophy of "Otsuka-people creating new products for better 1xbet.comalth worldwide," Otsuka Pharmaceutical Co., Ltd. is dedicated to contributing to t1xbet.com 1xbet.comalth of people around t1xbet.com world.
Overview of Rotigotine Phase III Clini1xbet.coml Trial in Japan
About Parkinson's disease
Parkinson's disease is a progressive degenerative neurological disorder (progressively impairing neurological functions without a known cause) characterized by t1xbet.com prominent symptoms of tremors at rest, rigidity, akinesia and impairment of postural reflexes. Parkinson's disease appears mostly in middle-aged and older people, and t1xbet.com disease affects about one out of every 1,000 persons. T1xbet.com disease is t1xbet.com second most prevalent degenerative neurological disorder following Alz1xbet.comimer's disease, and with populations aging around t1xbet.com world, t1xbet.com occurrence rate is expected to increase in t1xbet.com future.