drugs

Neupro - rotigotine

What is Neupro?

Neupro is a range of transdermal patches (ie based on the principle of administering the drug through the skin). Each patch releases 1, 2, 3, 4, 6 or 8 mg of the active ingredient

rotigotine in the briefcase.

What is Neupro used for?

Neupro is used to treat the symptoms of the following diseases in adults:

• Parkinson's disease. Neupro is used as monotherapy at the early stage of the disease or in combination with levodopa (another medicine used in Parkinson's disease), at any stage of the disease, including the terminal ones when levodopa starts to lose its effectiveness;

• moderate to severe restless legs syndrome, a disorder in which the patient experiences an uncontrollable need to move his limbs to cushion an uncomfortable, painful or abnormal body sensation, usually at night. Neupro is used where it is not possible to identify the specific cause of the disorder.

The medicine can only be obtained with a prescription.

How is Neupro used?

Neupro is applied once a day, at approximately the same time each day. The patch should be applied to clean, dry and intact skin, in correspondence with the abdomen (belly), thighs, hips, hips, shoulders or upper arm. The patch remains in contact with the skin for 24 hours and is subsequently replaced by a new plaster placed in a different site. Avoid reapplication at the same site of administration for 14 days.

At the initial stage of Parkinson's disease, the initial dose is 2 mg / 24 h; the dose is increased weekly by 2 mg / 24 h until an effective dose is reached or up to a maximum of 8 mg / 24 h. In most patients the effective dose is reached within three or four weeks.

For patients starting therapy, a special pack containing four different dosages is provided. If the medicine is not sufficient to control the disease, switching to another similar medicine may be beneficial. At an advanced stage of the disease, the initial dose is 4 mg / 24 h, then increased every week by 2 mg / 24 h, until an effective dose is reached or a maximum of 16 mg / 24 h. The application of certain doses may require more than one patch. For restless legs syndrome, the initial dose is 1 mg / 24 h. Depending on the patient's response, the dose may be increased every week by 1 mg / 24 h until an effective dose is reached or up to a maximum of 3 mg / 24 h. The need for continued treatment should be evaluated by a doctor every six months.

How does Neupro work?

The active ingredient in Neupro, rotigotine, is a dopamine agonist, meaning it mimics the action of dopamine. Dopamine is a substance responsible for the transmission of messages, contained in brain districts that control movement and coordination. In patients with Parkinson's disease, dopamine-producing cells begin to die, resulting in a decrease in the amount of dopamine present in the brain. Patients therefore lose the ability to control their movements reliably. Through the skin Neupro transfers a constant amount of rotigotine into the blood. Rotigotine subsequently stimulates the brain as would dopamine, allowing patients to control their movements and minimize the signs and symptoms of Parkinson's disease including stiffness and slowed movements.

In Restless Legs Syndrome, it is not entirely known how rotigotine works. This syndrome is believed to be due to problems related to the way dopamine works in the brain, which can be improved by rigotina.

How has Neupro been studied?

The efficacy of Neupro in the treatment of early stages of Parkinson's disease has been examined

in two studies involving a total of 830 patients. The studies measured the scores obtained, before and after treatment, in a standard questionnaire called Unified Parkinson's Disease Rating Scale (UPDRS, clinical reference scale for the quantification of motor disability and functional loss in Parkinson's disease). A 20% improvement in the post-treatment score was taken as an indicator of the benefits that could be considered relevant for patients. In the first study, the efficacy of Neupro was compared to that of placebo (a dummy treatment), while in the second trial it was compared with ropinirole (another dopamine agonist) and placebo. In the advanced stage of the disease, Neupro was studied in two studies involving a total of 842 patients. The measure of effectiveness was the length of the interval within a day when patients felt "out of play" (too many symptoms of Parkinson's disease to be able to live normally). In the first study, the efficacy of two different doses of Neupro was compared to that of placebo. In the second study, the comparison was with pramipexole (another dopamine agonist) and placebo.

For restless legs syndrome, Neupro was observed in two main studies involving a total of 963 patients with moderate to severe syndrome. The efficacy of the drug, in doses of 0.5 to 3 mg / 24 h, was compared with placebo. The main measure of effectiveness was the change in symptoms between the start of the study and after six months of treatment with a constant dose, measured as a function of two clinical reference scales.

What benefit has Neupro shown during the studies?

Neupro was more effective than placebo in the treatment of Parkinson's disease. In the initial phase of the disease, the scores obtained in the UPDRS with Neupro showed an improvement over placebo. There was an improvement in scores of 20% in 48-52% of patients treated with Neupro and in 19-30% of those treated with placebo. Neupro was less effective than ropinirole: a 20% improvement was seen in 68% of patients treated with ropinirole. In advanced disease, patients treated with Neupro experienced a greater reduction in "out-of-play" intervals than those treated with placebo (a decrease of 2.1-2.7 hours with Neupro compared to 0.9 with placebo ). The decrease with pramipexole was 2.8 hours.

For restless legs syndrome, patients who received doses of Neupro from 1 to 3 mg / 24 h reported a more marked improvement than those who received a placebo in the two studies performed, as detected by both reference scales.

What is the risk associated with Neuro?

The most frequent side effects seen with Neupro in Parkinson's disease patients (seen in more than 1 in 10 patients) are drowsiness, dizziness, nausea and application site reactions such as skin irritation and burning. In patients with restless legs syndrome, the most common side effects (seen in more than 1 patient in 10) are nausea, reactions at the site of application, fatigue and headache. To limit skin reactions it is important to follow the instructions for use of the patch. Drowsiness can compromise the patient's ability to drive. For the full list of all side effects reported with Neupro, see the Package Leaflet.

Neupro should not be used in people who may be hypersensitive (allergic) to rotigotine or any of the components. The Neupro reinforcement layer contains aluminum. To avoid skin burns, Neupro must be removed if the patient has to undergo a nuclear magnetic resonance (MRI) or cardioversion (a process that restores normal heart rhythm). For the full list of usage restrictions, see the package leaflet.

Why has Neupro been approved?

The Committee for Medicinal Products for Human Use (CHMP) has decided that Neupro's benefits in the symptomatic treatment of moderate to severe idiopathic leg syndrome in adult patients and for the treatment of signs and symptoms of idiopathic Parkinson's disease are superior to its risks.

The committee therefore recommended that Neupro be given marketing authorization.

What measures are being taken to ensure the safe use of Neupro?

The company that makes Neupro is performing a study of some of the side effects of the medicine found with similar medicines (sleepiness attacks and development of hard tissue in the heart valves).

Other information on Neupro:

On 15 February 2006, the European Commission issued a marketing authorization for Neupro to Schwarz Pharma Ltd., valid throughout the European Union.

The full EPAR for Neupro can be found here.

Last update of this summary: 07 - 2008