Otsuka Pharmaceutical Co., Ltd.

January 13, 2012

Otsuka Pharmaceutical Files New Drug Application for The Dopamine Agonist Transdermal Patch, Rotigotine Patch, in Japan

  • The world's only dopamine agonist*1 in the sustained-release patch formulation
  • Simultaneous application for the 2 indications of Parkinson's disease and restless legs syndrome*2

Tokyo, Japan, January 13, 2012 -- Otsuka Pharmaceutical Co., Ltd. today announced that the company submitted a manufacturing and marketing approval application in December 2011, for the dopamine agonist transdermal patch, Rotigotine*3 Patch which has been developed as a treatment for Parkinson's disease and restless legs syndrome.

Rotigotine Patch is the world's only dopamine agonist in once-daily transdermal patch formulation. Providing a continuous release of the drug substance, Rotigotine Patch can maintain a clinically effective blood drug concentration for 24 hours to achieve stable effects. The symptoms of Parkinson's disease and restless legs syndrome occur throughout the course of a day. Rotigotine Patch was developed to alleviate the symptoms that can occur during the day or night and to provide patients with a more convenient form of drug treatment.

Neupro® (brand name; nonproprietary name is rotigotine) is being marketed by the global biopharmaceutical company UCB as a treatment for Parkinson's disease or restless legs syndrome*4 in many countries throughout the world. Otsuka Pharmaceutical acquired the exclusive rights for developing and marketing Rotigotine Patch in Japan in 2002.

  • *1:Dopamine agonists work by binding to and stimulating dopamine receptors
  • *2:Moderate to severe idiopathic restless legs syndrome
  • *3:Non-proprietary name
  • *4:Symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults

About Parkinson's disease

Parkinson's disease is a progressive neurodegenerative disorder, the major symptoms of which are resting tremor, rigidity, akinesia, and postural reflex impairment. Most Parkinson's disease patients are middle-aged or elderly and the prevalence rate of the disease is said to be approximately one in 1,000 people. Parkinson's disease is the second most common neurodegenerative disease after Alzheimer disease, and its prevalence is expected to increase with the aging of the population.

An issue that has faced Parkinson's disease patients is that symptoms such as dysphagia and hand tremor that often accompany Parkinson's disease make it difficult to continue taking medication. It is important to maintain a certain level of plasma dopamine concentration throughout the day to suppress the various symptoms associated with the disease. Also, because of the need for long-term treatment, an easy-to-use and convenient dopamine agonist that enables patients to continue using the drug has been much hoped for.

About restless legs syndrome

Restless legs syndrome RLS), also called muzu-muzu ashi syndrome in Japan or Ekbom disease (after its discoverer, Dr. Ekbom), is estimated to occur in 1.5 percent of the adult population in Japan, with most patients over the age of 40, and women in particular having a high prevalence rate. RLS affects the quality of life of over 2 million patients, yet in most cases RLS is misdiagnosed as insomnia or some other disease because RLS is still a relatively unknown disease. Therefore, many patients today do not receive sufficient treatment for the disorder.

RLS, which primarily manifests itself in 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 from patient to patient, with such complaints as restlessness in the calves and itchiness, burning, or pain along the inside of the legs, and symptoms become worse when sitting or lying down, appearing most often before bedtime. As such, RLS is known to cause difficulty falling asleep.

In patients with RLS, some symptoms worsen before sleep and symptoms also appear when patients sit still for long hours during the day, such as for business meetings. The occurrence of symptoms before and during sleep, in particular, creates sleep disorder and reduces quality of life. Therefore, a drug product with stable efficacy throughout the day has been much hoped for.