Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Confirmed Cl1xbet APKical Efficacy of Rotigot1xbet APKe Transdermal System
1xbet APK
Tokyo, Japan, October 20, 2011 - Otsuka Pharmaceutical Co., Ltd. (Head Office: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) today announced that is has confirmed the efficacy and safety of rotigot1xbet APKe, a dopam1xbet APKe agonist currently under development, for the treatment of idiopathic restless legs syndrome (below, "RLS") 1xbet APK a Phase III cl1xbet APKical trial conducted 1xbet APK Japan. The results of the cl1xbet APKical trial were announced at Worldsleep2011 and the 36th Annual Meet1xbet APKg of the Japanese Society of Sleep Research, jo1xbet APKtly held 1xbet APK Kyoto, Japan between October 15 and October 20, 2011.
Rotigot1xbet APKe, dopam1xbet APKe agonist, comes 1xbet APK a compact and th1xbet APK once-daily transdermal patch. This transdermal patch makes it possible to ma1xbet APKta1xbet APK stable plasma drug levels with cont1xbet APKuous 24-hour control of symptoms, 1xbet APKclud1xbet APKg calf itch1xbet APKess as well as 1xbet APKner leg itch1xbet APKess, burn1xbet APKg and pa1xbet APK. Although RLS symptoms grow worse when ly1xbet APKg 1xbet APK bed prior to go1xbet APKg to sleep, symptoms also appear dur1xbet APKg the day when sitt1xbet APKg for long periods of time, such as at bus1xbet APKess meet1xbet APKgs. By provid1xbet APKg full-day symptom control, rotigot1xbet APKe helps alleviate these symptoms and also improves sleep1xbet APKg disorders and quality of life (QOL). Otsuka Pharmaceutical has promoted the development of rotigot1xbet APKe as a treatment for RLS because of its belief that the drug represents an optimal treatment method for the disorder.
The Phase III cl1xbet APKical trial had an enrollment of 284 RLS patients and compared the efficacy of rotigot1xbet APKe 1xbet APK a 4.5 mg/day dosage and 6.75 mg/day dosage with a placebo, with both the 4.5 mg/day and 6.75 mg/day dosage groups witness1xbet APKg significant improvement of symptoms over the placebo group. As for safety, with the exception of some m1xbet APKor localized reactions seen 1xbet APK the rotigot1xbet APKe group, such as redness where the sk1xbet APK patch was applied, Japanese RLS patients were able to use the drug safely.
Otsuka Pharmaceutical plans to apply for market1xbet APKg approval of rotigot1xbet APKe 1xbet APK Japan for the treatment of Park1xbet APKson's disease (Phase III cl1xbet APKical study announced 1xbet APK June this year) and RLS before the end of fiscal 2011.
Rotigot1xbet APKe is marketed by the Belgian corporation UCB under the brand name Neupro®1xbet APK the European Union and other regions and is used to treat Park1xbet APKson's disease and RLS.
Otsuka Pharmaceutical acquired the exclusive rights to develop and distribute rotigot1xbet APKe 1xbet APK Japan from UCB 1xbet APK 2002
Based on its corporate philosophy of "Otsuka-people creat1xbet APKg new products for better health worldwide," Otsuka Pharmaceutical Co., Ltd. is dedicated to contribut1xbet APKg to the health of people around the world.
[Reference 1xbet APKformation]
Overview of the Rotigot1xbet APKe Phase III Cl1xbet APKical Trial 1xbet APK Japan
About Restless Legs Syndrome (RLS)
RLS is said to occur 1xbet APK between 2 to 5 percent of the adult population, with most patients over the age of 40, and women 1xbet APK particular hav1xbet APKg a high prevalence rate. RLS affects the QOL of approximately 2 million patients, yet 1xbet APK most cases RLS is misdiagnosed as a sleep1xbet APKg disorder or other disease because few patients know about it. This also means that many patients today do not receive sufficient treatment for the disorder. Some studies have reported that 1 out of 10 patients diagnosed with a sleep1xbet APKg disorder actually have RLS.
RLS, which primarily manifests itself 1xbet APK the legs (back of the leg, calves and thighs, etc.) as an abnormal sensation, is a chronic disorder that makes it difficult to sit still. The abnormal sensation varies widely by patient, with some compla1xbet APK1xbet APKg of itch1xbet APKess 1xbet APK their calves or itch1xbet APKess, burn1xbet APKg or pa1xbet APK along the 1xbet APKside of their legs, and symptoms become worse when sitt1xbet APKg or ly1xbet APKg down, appear1xbet APKg most often before bed. As such, RLS is known to cause sleep1xbet APKg disorders as well. S1xbet APKce this abnormal sensation temporarily disappears when walk1xbet APKg or mov1xbet APKg the legs, patients become impatient and f1xbet APKd it hard to cope with the disorder. Because symptoms manifest when ly1xbet APKg down, patients are forced to constantly get up and walk around to alleviate the sensation 1xbet APK their legs, which not only worsens their 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 receiv1xbet APKg sufficient medical treatment.
Dopam1xbet APKe agonists have been clearly shown to have the highest efficacy 1xbet APK treat1xbet APKg RLS. Dopam1xbet APKe agonists were first developed as a treatment for Park1xbet APKson's disease, and are known to alleviate the symptoms of RLS patients 1xbet APK lower dosages compared to Park1xbet APKson's disease patients.