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Boehringer Ingelheim Receives Recommendation From EU Scientific Committee for Sifrol(R)/ Mirapexin(R) (Pramipexole) for the Treatment of Restless Legs Syndrome (RLS)
Ingelheim, Germany (ots/PRNewswire) -
- For Non-US Healthcare Professional Media
Boehringer Ingelheim announced today that that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of Sifrol(R) / Mirapexin(R) (pramipexole) for the treatment of Restless Legs Syndrome (RLS) in the European Union. Pramipexole is a dopamine agonist currently approved for the treatment of Parkinson's Disease. A supplementary new drug application (sNDA) has been filed with the US Food and Drug Administration (FDA) to include treatment of RLS in the US label also.
"Restless Legs Syndrome is a common yet very under-diagnosed condition which adversely affects the lives of millions of people worldwide. Global epidemiologic and quality of life studies show a significant impact on RLS-patients' quality of life, comparable to that of cardiovascular diseases . The recommendation from the EU scientific committee will be welcomed by the clinical community as it reflects recognition of the need for effective treatment options for the many patients who are suffering from this debilitating condition." Professor Claudia Trenkwalder, Department of Clinical Neurophysiology, University of Goettingen, Goettingen, Germany, commented.
"Boehringer Ingelheim is committed to improving the lives of patients suffering from Restless Legs Syndrome," said Dr. Andreas Barner, member of the Board of Managing Directors of Boehringer Ingelheim and responsible for Research & Development and Medicine. "The recommendation from the CHMP is a major step towards an approval for pramipexole in the European Union. A final decision from the European Commission could be expected in the second quarter of 2006. Pramipexole is already well established in the treatment of Parkinson's Disease - our hope is that soon RLS patients will be able to benefit from the efficacy of pramipexole in controlling not only the symptoms of RLS, but also in reducing the high impact of the disease on patients' quality of life."
If approved, this pharmaceutical treatment for Restless Legs Syndrome will be marketed throughout the European Union by Boehringer Ingelheim.
The CHMP Opinion stated that Sifrol(R)/Mirapexin(R) tablets are indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).
Efficacy in treating RLS
The registration programme for pramipexole included more than 1,000 patients in Europe and the United States. These study results have confirmed that pramipexole provides rapid relief from symptoms after just one week of starting treatment. Pramipexole is highly efficacious at the starting dose of 0.125mg single dose per day and up to 0.75mg single dose per day and is well tolerated ,,.
The efficacy and tolerability of pramipexole in RLS continues to be investigated in a comprehensive clinical trials programme with more than 1,000 patients, to further assess the therapeutic potential in this condition.
About Restless Legs Syndrome (RLS)
RLS is a neurological disorder characterised by an uncontrollable urge to move the legs, usually accompanied by unpleasant and sometimes painful sensations in the legs. RLS affects up to ten percent of the population aged between 30 and 79 years and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress. The motor-restlessness worsens during the evening and night causing difficulty initiating and maintaining sleep. The sleep disruption can lead to excessive daytime sleepiness and compromise work performance. RLS also has considerable impact on social activities that require immobility.
Pramipexole, a compound from Boehringer Ingelheim research, is currently approved for the treatment of the signs and symptoms of idiopathic Parkinson's Disease, as monotherapy or in combination with levodopa. The most commonly reported adverse reactions in early and late Parkinson's disease in clinical trials were dizziness, dyskinesia, headache, insomnia, somnolence, constipation, nausea, hallucinations visual, orthostatic hypotension and fatigue. Patients have reported falling asleep without perceived warning signs during activities of daily living, including operation of a motor vehicle, which sometimes resulted in accidents. As also described in the literature for antiparkinsonian dopamine replacement therapy, cases of behavioural changes have been reported.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 144 affiliates in 45 countries and nearly 36,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2004, Boehringer Ingelheim posted net sales of 8.2 billion euro while spending nearly one fifth of net sales in its largest business segment Prescription Medicines on research and development.
For more information please visit www.boehringer-ingelheim.com
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