UCB announced today that Neupro® (Rotigotine Transdermal System) is now available in U.S. pharmacies. Neupro® was approved by the U.S Food and Drug Administration in April to treat the signs and symptoms of early and advanced stage idiopathic Parkinson’s disease and moderate-to-severe primary Restless Legs Syndrome.
Neupro® improves motor function and activities of daily living in patients with PD and provides effective symptom relief for patients with Restless Legs Syndrome (RLS). Neupro® is a once-daily patch that provides continuous delivery of the dopamine agonist rotigotine for 24 hours.
Over 100,000 patients have been treated with Neupro® worldwide, and seven clinical trials for the approved indications have demonstrated efficacy, safety and tolerability.
“The availability of Neupro® is an important step forward for U.S. patients living with Parkinson’s disease and Restless Legs Syndrome,” said Roch Doliveux, Chief Executive Officer, UCB. “UCB is dedicated to delivering innovative medicines like the Neupro® transdermal patch to people living with serious illnesses such as Parkinson’s disease and Restless Legs Syndrome, by combining the latest science and technology with our researchers’ insights on the holistic needs of patients.”
One million Americans are currently living with PD. The cardinal motor symptoms of PD include stiffness, tremors, slow movements and postural instability. These symptoms can have a broad impact on patients’ lives.
Restless Legs Syndrome may affect up to 23 million Americans. Patients with RLS often experience uncomfortable sensations in the legs, feet, arms, torso or head that typically occur during periods of rest and inactivity. Symptoms occur predominantly at night, but may emerge at any point in the day or night. Unmanaged moderate-to-severe RLS, in which patients experience symptoms two or more times a week, can be particularly disruptive for patients.
“Parkinson’s disease and Restless Legs Syndrome are serious, neurological diseases,” said Dr. Joseph Jankovic, Professor of Neurology and Director, Parkinson’s Disease Center and Movement Disorders Clinic, Baylor College of Medicine, Houston, Texas. “The often unpredictable, debilitating nature of these diseases can require consistent, sustained symptom control throughout the day and night.”
Data Demonstrated Significant Symptom Improvement for Parkinson’s Disease and Restless Legs Syndrome
The effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic PD was established in five parallel group, randomized, double-blind placebo-controlled trials conducted in the U.S. and abroad. Depending on trial design, PD patients underwent a weekly titration of rotigotine in 2 mg/24 hours increments to either the randomized dose or optimal dose.
Three early PD trials used the Unified Parkinson’s Disease Rating Scale (UPDRS), a multi-item, four-part rating scale commonly used in PD trials. Parts II and III of the UPDRS were combined to measure improvement or worsening of activities of daily living (ADL) and motor performance. Parts II and III contain 13 questions that allow clinicians to evaluate aspects of ADL – such as speech, dressing, and cutting food with utensils – and 27 questions related to the cardinal motor symptoms in PD patients, tremor, rigidity, bradykinesia, and postural instability. The trials showed rotigotine was effective in helping to improve movement and function, versus placebo, in patients with early PD.
Two trials of rotigotine in patients with advanced PD examined change from baseline in “off” time, periods when the effectiveness of medication wears off and PD symptoms return. Statistically significant reductions in off-times were observed in advanced PD patients receiving rotigotine compared with those who received placebo.
The efficacy of rotigotine in the treatment of RLS was primarily evaluated in two fixed-dose, randomized, double-blind, placebo-controlled trials with six-month maintenance periods. Patients received rotigotine doses ranging from 0.5 mg/24 hours to 3 mg/24 hours, or placebo, once daily. In these trials, rotigotine provided significant RLS symptom improvement versus placebo for RLS patients, as measured by two widely-accepted tools that allowed patients and clinicians to assess and rank symptom improvement.
The International RLS Study (IRLS) Group rating scale contains 10 items that ask the patient to assess on a scale of zero to 40, with zero being absence of RLS symptoms and 40 being most severe, the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood associated with RLS. The Clinical Global Impression – Improvement scale, or CGI-I, allows the healthcare provider to assess how much the patient’s illness has improved or worsened compared to a baseline state established at the beginning of the trial. The scale ranges from 1, very much improved, to 7, very much worse.
In clinical trials, the most common adverse reactions (≥5% greater than placebo) for the highest recommended doses of Neupro® for treatment of Parkinson’s disease were nausea, vomiting, somnolence, application site reactions, dizziness, anorexia, hyperhidrosis, insomnia, peripheral edema, and dyskinesia. The most common adverse reactions (≥5% greater than placebo) for the highest recommended dose of Neupro® for treatment of Restless Legs Syndrome were application site reactions, nausea, somnolence, and headache.
Neupro® is available in four different dosage strengths for the signs and symptoms of Parkinson’s disease (2 mg/24 hours, 4 mg/24 hours, 6 mg/24 hours, and 8 mg/24 hours). For moderate-to-severe primary RLS, dosing is available in three different dosage strengths (1 mg/24 hours, 2 mg/24 hours, and 3 mg/24 hours).
About Parkinson’s disease
Parkinson’s disease develops with the loss of nerve cells in the brain that produce a chemical called dopamine. The symptoms of PD include both motor and other system involvement and can have a broad impact on patients. As dopamine levels fall, movement (motor) symptoms – tremors (uncontrollable shaking), rigidity (stiffness or muscle tensing) and bradykinesia (slowness and loss of spontaneous movement) – can progress, along with other underlying symptoms of PD.
About Restless Legs Syndrome
RLS is characterized by unpleasant sensations in the legs and an uncontrollable urge to move to gain relief. Most people with RLS have difficulty falling asleep and staying asleep.
Studies have shown that many patients with RLS may also experience symptoms during the day. Daytime symptoms of RLS, such as inability to sit still and involuntary leg jerks, are increasingly recognized. RLS can result in exhaustion and daytime fatigue, and may affect daily activities. Patients with moderate-to-severe RLS may require long-term treatment for their RLS.
While the underlying pathophysiology of RLS is not fully understood, it is thought to involve central dopamine systems. Recent neuroimaging data suggest that RLS patients may carry an abnormality in dopamine transport that can be visualized both day and night.