UCB 
By Data from a non-interventional, observational study of 76 patients presented at the 65th American Academy of Neurology Annual Meeting
Brussels (Belgium), March 19th 2013 - 1800 CEST - UCB today announced data from a non-interventional, observational study conducted in Germany that found that when Parkinson's disease (PD) patients were switched from an oral PD medication to Neupro® (Rotigotine Transdermal System), they reported improvements in pre-existing gastrointestinal symptoms (GI) symptoms. The data were presented at the American Academy of Neurology's (AAN) 2013 Annual Scientific Meeting in San Diego, March 16-23, 2013.
"GI symptoms are common non-motor symptoms in PD patients, and can significantly affect their daily life," said Dirk Woitalla, MD, lead study author, St. Josef-Hospital Universitätsklinik. "The findings presented at AAN show the potential improvement rotigotine may have on these symptoms for people living with PD. Controlled clinical studies are needed to confirm this finding."
In the study conducted in a clinical practice setting in Germany, PD patients experiencing GI symptoms (e.g., heartburn, bloating, nausea, vomiting, abdominal pain or diarrhea) while receiving oral drug treatment were switched by their physician to rotigotine transdermal system.1
Primary efficacy outcomes included changes in GI symptoms (measured by a visual analogue scale [intensity; 0-100 mm]) and the sum score of GI complaints (six items each rated 0-12 for sum of 0-72), in addition to patient satisfaction in relation to GI symptoms approximately six weeks after treatment switch.1
Of the 76 patients enrolled in the study, 58 had follow up data available for final analysis. The intensity of GI complaints improved numerically on the visual analogue scale (47.5±24.4 mm at baseline; 19.7±23.3 mm after approximately six weeks), as well as the sum score of GI complaints (11.2±9.0 at baseline; 2.1±4.4 after approximately six weeks). Fifty of the 58 patients reported being satisfied or very satisfied with the improvement in GI symptoms after approximately 6 weeks of treatment with rotigotine transdermal system. The study suggests that a switch from oral PD medication to rotigotine transdermal system may improve pre-existing GI symptoms among patients with PD.1 Neupro® can cause nausea, vomiting, and gastrointestinal distress, which may occur more frequently during initial therapy.
Neupro® is approved in the U.S. to treat the signs and symptoms of idiopathic PD.2 In the European Union, Neupro® is approved for the treatment of the signs and symptoms of early-stage idiopathic PD, as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur.3
About Parkinson's disease
Parkinson's disease is a chronic neurological condition that develops with the loss of nerve cells in the brain that produce a chemical called dopamine.4 The symptoms of PD include both motor and non-motor symptoms and can have a broad impact on patients.5 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 non-motor symptoms of PD.4
Notes to Editors
About Neupro® in the U.S.
Neupro® (Rotigotine Transdermal System) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome (RLS). For more information about Neupro visit www.neupro.com.
Neupro® in the U.S. Important Safety Information
Neupro® contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people and is seen more frequently in people with asthma.
Patients treated with Neupro® have reported somnolence and falling asleep without warning signs during activities of daily living, including driving, which sometimes resulted in accidents. Some patients believed they were alert immediately prior to the event. Patients may not recognize or acknowledge increased drowsiness or sleepiness. Therefore, prescribers should directly question patients about these possible occurrences and continually reassess patients, as some events have been reported well after
the start of treatment. Patients should be advised to exercise caution while driving, operating heavy machinery, or working at heights during treatment with Neupro®. If patients develop daytime sleepiness or episodes of falling asleep during activities of daily living, Neupro® should be discontinued.
There is an increased risk for hallucinations in patients with advanced-stage Parkinson's disease treated with Neupro®. Patients also may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior during Neupro® treatment or after starting or increasing the dose of Neupro®.
Neupro® may cause symptomatic postural/orthostatic hypotension, and Parkinson's disease patients appear to have an impaired capacity to respond to postural challenge. Both Parkinson's and RLS patients treated with dopamine agonists require careful monitoring for signs and symptoms of postural hypotension, especially during dose escalation, and should be informed of this risk. Neupro® may also cause syncope, elevated blood pressure, elevated heart rate, weight gain, and fluid retention. Neupro®
should be used with caution in patients with severe cardiovascular disease.
Case reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and other intense urges, and the inability to control these urges while taking medications, including Neupro®, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson's disease. Because patients may not recognize these behaviors as abnormal, prescribers should specifically ask patients and their caregivers about the development of new or increased urges while being treated with Neupro®. Dose reduction or discontinuation of Neupro® should be considered if such urges develop.
Neupro® may increase the dopaminergic side effects of levodopa and may cause and/or exacerbate preexisting dyskinesia.
Neupro® can cause application site reactions, and some may be severe. In clinical trials, most reactions were mild or moderate in intensity and were limited to the patch area.
Patients with Parkinson's disease have a higher risk of developing melanoma than the general population. Patients should be monitored for melanomas frequently when using Neupro®.
Dopaminergic medicinal products, including Neupro®, may cause augmentation and rebound in RLS patients.
Neupro® should be removed before magnetic resonance imaging or cardioversion, because the aluminum backing layer in the patch could cause skin burns. Heat application has been shown to increase absorption several fold with other transdermal products. Therefore, patients should be advised to avoid exposing the application site to sources of direct heat, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight.
The most common adverse reactions (
