Otsuka Pharmaceutical Co., Ltd.

December 25, 2012

The World's Only Transdermal Dopamin Agonist, Neupro® Patch, Approved in Japan for Both Parkinson's Disease and Restless Legs Syndrome

  • The only transdermal dopamine agonist*1 system, which helps maintain a stable blood concentration of the drug treatment for 24 hours with once a day application
  • Approved with indications for both Parkinson's Disease and Restless Legs*2 Syndrome
  • Many patients are not satisfied with their treatment for Parkinson's Disease, and are long awaiting for drug which will be able to provide stable efficacy throughout the day to overcome their daily difficulties, such as not being able to move upon awakening

Tokyo, Japan, December 25, 2012 - Otsuka Pharmaceutical Co., Ltd. (Head Office: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) has received regulatory approvals today in Japan for Neupro® Patch (chemical name is rotigotine), indicated for both Parkinson's disease and Restless Legs Syndrome.

Neupro® Patch is a transdermal dopamine agonist system, which needs to be applied only once a day, enabling a clinically effective blood drug concentration via stable drug delivery throughout a 24-hour period.

Parkinson's disease is a degenerative neurological disease, typically characterized by four symptoms, which are uncontrollable shaking, muscle rigidity, slowness of movement movement) and impairment of upright body posture.

Many patients with Parkinson's disease have had experiences of drug efficacy diminishing or ceasing during certain times of the day, and as a result they often suffer from difficulty in falling asleep or not being able to move once they wake up in the morning, for example. Neupro® Patch is expected to provide relief for both patients and their caregivers, as it needs to be applied only once a day in order to achieve a stable blood drug concentration which lasts for 24 hours.

Restless Legs Syndrome is a chronic neurological disorder, characterized by abnormal sensations, particularly in the patients' calves, thighs and feet. Patients are not able to stay still due to these unpleasant sensations which are often expressed as creeping, itchy, or prickly feelings within or around the legs, although the expression varies from patient to patient. These sensations are often felt at rest in the evening, such as at bedtime, and are known to prevent sound sleep.

Patients with Restless Legs Syndrome can suffer when sedentary during daytime hours as well. Neupro® Patch can alleviate Restless Legs Syndrome symptoms throughout the day via simple application of a once-a-day patch which delivers a stable dopaminergic treatment lasting for 24 hours.

Otsuka Pharmaceutical acquired in 2002 the exclusive rights for developing and marketing Neupro® Patch in Japan. Outside of Japan, it is approved in over 50 countries as Neupro® for treatment of Parkinson's disease, and approved in over 30 countries indicated for the treatment of Restless Legs Syndrome*3 by the product's owner, UCB, the global biopharmaceutical company based in Belgium.

Otsuka Pharmaceutical is pleased to introduce Neupro® Patch to Japan, which is the only transdermal dopamine agonist available in the world, and by doing so we will strive to address unmet medical needs of Parkinson's disease and Restless Legs Syndrome in Japan.

  • *1:Dopamine agonists work by binding to and stimulating dopamine receptors
  • *2:Moderate to severe idiopathic restless legs syndrome
  • *3:Symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults