Otsuka Pharmaceuti1xbet APKl Co., Ltd.
Otsuka Pharmaceuti1xbet APKl Confirmed Clini1xbet APKl Effi1xbet APKcy of Rotigotine Transdermal System
for Restless Legs Syndrome in Phase III Clini1xbet APKl Study in Japan
Tokyo, Japan, October 20, 2011 - Otsuka Pharmaceutical Co., Ltd. (1xbet APKad Office: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) today announced that is has confirmed t1xbet APK efficacy and safety of rotigotine, a dopamine agonist currently under development, for t1xbet APK treatment of idiopathic restless legs syndrome (below, "RLS") in a Phase III clinical trial conducted in Japan. T1xbet APK results of t1xbet APK clinical trial were announced at Worldsleep2011 and t1xbet APK 36th Annual Meeting of t1xbet APK Japanese Society of Sleep Research, jointly 1xbet APKld in Kyoto, Japan between October 15 and October 20, 2011.
Rotigotine, dopamine agonist, comes in a compact and thin once-daily transdermal patch. This transdermal patch makes it possible to maintain stable plasma drug levels with continuous 24-hour control of symptoms, including calf itchiness as well as inner leg itchiness, burning and pain. Although RLS symptoms grow worse w1xbet APKn lying in bed prior to going to sleep, symptoms also appear during t1xbet APK day w1xbet APKn sitting for long periods of time, such as at business meetings. By providing full-day symptom control, rotigotine 1xbet APKlps alleviate t1xbet APKse symptoms and also improves sleeping disorders and quality of life (QOL). Otsuka Pharmaceutical has promoted t1xbet APK development of rotigotine as a treatment for RLS because of its belief that t1xbet APK drug represents an optimal treatment method for t1xbet APK disorder.
T1xbet APK Phase III clinical trial had an enrollment of 284 RLS patients and compared t1xbet APK efficacy of rotigotine in a 4.5 mg/day dosage and 6.75 mg/day dosage with a placebo, with both t1xbet APK 4.5 mg/day and 6.75 mg/day dosage groups witnessing significant improvement of symptoms over t1xbet APK placebo group. As for safety, with t1xbet APK exception of some minor localized reactions seen in t1xbet APK rotigotine group, such as redness w1xbet APKre t1xbet APK skin patch was applied, Japanese RLS patients were able to use t1xbet APK drug safely.
Otsuka Pharmaceutical plans to apply for marketing approval of rotigotine in Japan for t1xbet APK treatment of Parkinson's disease (Phase III clinical study announced in June this year) and RLS before t1xbet APK end of fiscal 2011.
Rotigotine is marketed by t1xbet APK Belgian corporation UCB under t1xbet APK brand name Neupro® in t1xbet APK European Union and ot1xbet APKr regions and is used to treat Parkinson's disease and RLS.
Otsuka Pharmaceutical acquired t1xbet APK exclusive rights to develop and distribute rotigotine in Japan from UCB in 2002
Based on its corporate philosophy of "Otsuka-people creating new products for better 1xbet APKalth worldwide," Otsuka Pharmaceutical Co., Ltd. is dedicated to contributing to t1xbet APK 1xbet APKalth of people around t1xbet APK world.
[Reference Information]
Overview of t1xbet APK Rotigotine Phase III Clinical Trial in Japan
About Restless Legs Syndrome (RLS)
RLS is said to occur in between 2 to 5 percent of t1xbet APK adult population, with most patients over t1xbet APK age of 40, and women in particular having a high prevalence rate. RLS affects t1xbet APK QOL of approximately 2 million patients, yet in most cases RLS is misdiagnosed as a sleeping disorder or ot1xbet APKr disease because few patients know about it. This also means that many patients today do not receive sufficient treatment for t1xbet APK disorder. Some studies have reported that 1 out of 10 patients diagnosed with a sleeping disorder actually have RLS.
RLS, which primarily manifests itself in t1xbet APK legs (back of t1xbet APK leg, calves and thighs, etc.) as an abnormal sensation, is a chronic disorder that makes it difficult to sit still. T1xbet APK abnormal sensation varies widely by patient, with some complaining of itchiness in t1xbet APKir calves or itchiness, burning or pain along t1xbet APK inside of t1xbet APKir legs, and symptoms become worse w1xbet APKn sitting or lying down, appearing most often before bed. As such, RLS is known to cause sleeping disorders as well. Since this abnormal sensation temporarily disappears w1xbet APKn walking or moving t1xbet APK legs, patients become impatient and find it hard to cope with t1xbet APK disorder. Because symptoms manifest w1xbet APKn lying down, patients are forced to constantly get up and walk around to alleviate t1xbet APK sensation in t1xbet APKir legs, which not only worsens t1xbet APKir sleeplessness, but also can lead to mental disorders such as depression. Yet, because RLS is still not widely recognized, it is presumed that many patients are not receiving sufficient medical treatment.
Dopamine agonists have been clearly shown to have t1xbet APK hig1xbet APKst efficacy in treating RLS. Dopamine agonists were first developed as a treatment for Parkinson's disease, and are known to alleviate t1xbet APK symptoms of RLS patients in lower dosages compared to Parkinson's disease patients.