Boehringer Ingelheim announced that the European Commission has approved Sifrol�/Mirapexin� (pramipexole) for the treatment of moderate to severe Restless Legs Syndrome (RLS) in the European Union. Pramipexole has been shown to provide clinically significant relief from the broad range of symptoms associated with RLS and is the first medication to be approved throughout the European Union for this indication.

Until now, there have been limited treatment options available to alleviate the symptoms of RLS, which can significantly impact patients' quality of life. Therefore, this announcement is expected to bring new hope to the millions of people throughout Europe who are affected by this debilitating condition.1

Professor Claudia Trenkwalder, MD, University of Goettingen and Head of the Paracelsus-Elena-Klinik, Kassel, Germany, commented, "Restless Legs Syndrome is a surprisingly common, but underdiagnosed condition, that adversely affects the lives of millions of people worldwide. Not only the physical symptoms, such as the uncontrollable urge to move the legs, but also the emotional symptoms of RLS can profoundly impact the patient`s quality of life. People with RLS commonly experience difficulties falling asleep or staying asleep, and daytime symptoms such as exhaustion, fatigue, sleepiness, and concentration difficulties, which can produce a tendency to become depressed. The approval of pramipexole in Europe means patients with this condition will now be able to benefit from effective and well-tolerated relief from a broad range of RLS symptoms, helping them to enjoy their everyday life."

Boehringer Ingelheim had also filed a supplementary new drug application with the US Food and Drug Administration (FDA) seeking an expansion of pramipexole's US label to include treating RLS.

Mirapex�/Sifrol�/Mirapexin� is the worldwide most prescribed dopamine agonist for the treatment of Parkinson's Disease and was first licensed in 1997.

"Boehringer Ingelheim is committed to realising the full therapeutic potential of its existing medicines and to providing patients with better and safer treatment options. The approval of pramipexole in the EU for the treatment of RLS will provide new hope to patients who, up until now, may have been suffering in silence," said Dr. Alessandro Banchi, Chairman of the Board of Managing Directors at Boehringer Ingelheim.

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 day2 and is well tolerated.3,4,5

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 worldwide aged between 30 and 79 years6 and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress.7 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.

About pramipexole

Pramipexole (known in Europe under the trade names Sifrol� and Mirapexin� and in the U.S.A. as Mirapex�), is a compound from Boehringer Ingelheim research first licensed in 1997 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. It should be noted that impulse control disorders/compulsive behaviours can occur while taking medicines to treat Parkinson`s disease, including pramipexole.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 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 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.

References:

1 Hening W et al Impact, diagnosis and treatment of restless legs syndrome in a primary care population: the REST (RLS epidemiology, symptoms and treatment) primary care study Sleep Med 2004; 5(3): 237-246

2 Oertel W, Stiasny-Kolster K. Early and persistent effect of pramipexole in RLS patients already with the starting dose. Movement Disorders 2005, 20 (Suppl 10): S58-S59

3 Winkelman J; Sethi K; Kushida C; Becker P; Mahowald M. Pramipexole is efficacious and safe in treating RLS patients: results of a 12 weeks placebo controlled, fixed dose study. Sleep Med2005; 6 (Suppl 2): S74

4 Partinen M; Hirvonen K; Alakuijala A; Jama L; Terttunen J. Rapid relief from RLS symptoms with pramipexole: results of a large polysomnographic study. Neurology 2004; 63 (8):1545

5 C. Trenkwalder, K. Stiasny-Kolster and the German RLS-Pramipexole Study Group. Sustained efficacy of Pramipexole in Restless Legs Syndrome. Sleep Med 2005; 6 (Suppl 2): S73

6 Phillips B et al Epidemiology of restless legs symptoms in adults Arch Intern Med 2000; 160(14): 2137-2141

7 Allen RP, Walters AS, Montplaisir J, Hening W, Myers A, Bell TJ, et al. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med 2005; 165 :1286 -1292

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