June 8, 2011
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical confirmed clinical efficacy of rotigotine trandermal system in Phase III clinical 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 the efficacy and safety of rotigotine, a non-ergoline dopaminergic agent for the treatment of Parkinson's disease, in a Phase III clinical trial. The results of this trial were presented at the MDS* 15th International Congress of Parkinson's Disease and Movement Disorders held in Toronto, Canada from June 5 to June 9, 2011.
- * MDS: Movement Disorders Society
Rotigotine is currently being developed as the first patch in Japan for the treatment of Parkinson's disease. The unique once daily skin patch preparation is expected to provide stable drug levels in the bloodstream with continuous symptom control throughout the day and night.
The 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 the drug's remedial effect on tremors, posture and stiffness using the UPDRS Part III total score.
Over the 16-week dosing period, the response of patients treated with rotigotine showed statistically significant superiority compared to placebo and non-inferiority to ropinirole. For the evaluation of the drug's safety, no cases of death or fatal adverse events were observed. The most frequent adverse event seen in the group administered rotigotine was application site reactions.
Given the results of the Phase III clinical trial, Otsuka Pharmaceutical plans to file for regulatory approval to market rotigotine in Japan during the fiscal year 2011. Rotigotine is approved under the brand name Neupro® in the European Union and other regions for the treatment of Parkinson's disease and Restless Legs Syndrome where it is marketed by UCB. In 2002, Otsuka acquired the exclusive development and marketing rights to Neupro® for the Japanese market from UCB.
Based on its corporate philosophy of "Otsuka-people creating new products for better health worldwide," Otsuka Pharmaceutical Co., Ltd. is dedicated to contributing to the health of people around the world.
Overview of Rotigotine Phase III Clinical 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 the 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 the disease affects about one out of every 1,000 persons. The disease is the second most prevalent degenerative neurological disorder following Alzheimer's disease, and with populations aging around the world, the occurrence rate is expected to increase in the future.
Information in this news release was current as of the original release date.