2006-02-24

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 forMedicinal Products for Human Use (CHMP) of the European MedicinesAgency (EMEA) has issued a positive opinion recommending approval ofSifrol(R) / Mirapexin(R) (pramipexole) for the treatment of RestlessLegs Syndrome (RLS) in the European Union. Pramipexole is a dopamineagonist currently approved for the treatment of Parkinson's Disease.A supplementary new drug application (sNDA) has been filed with theUS Food and Drug Administration (FDA) to include treatment of RLS inthe US label also.

"Restless Legs Syndrome is a common yet very under-diagnosedcondition which adversely affects the lives of millions of peopleworldwide. Global epidemiologic and quality of life studies show asignificant impact on RLS-patients' quality of life, comparable tothat of cardiovascular diseases [1]. The recommendation from the EUscientific committee will be welcomed by the clinical community as itreflects recognition of the need for effective treatment options forthe many patients who are suffering from this debilitatingcondition." Professor Claudia Trenkwalder, Department of ClinicalNeurophysiology, University of Goettingen, Goettingen, Germany,commented.

"Boehringer Ingelheim is committed to improving the lives ofpatients suffering from Restless Legs Syndrome," said Dr. AndreasBarner, member of the Board of Managing Directors of BoehringerIngelheim and responsible for Research & Development and Medicine."The recommendation from the CHMP is a major step towards an approvalfor pramipexole in the European Union. A final decision from theEuropean Commission could be expected in the second quarter of 2006.Pramipexole is already well established in the treatment ofParkinson's Disease - our hope is that soon RLS patients will be ableto benefit from the efficacy of pramipexole in controlling not onlythe symptoms of RLS, but also in reducing the high impact of thedisease on patients' quality of life."

If approved, this pharmaceutical treatment for Restless LegsSyndrome will be marketed throughout the European Union by BoehringerIngelheim.

The CHMP Opinion stated that Sifrol(R)/Mirapexin(R) tablets areindicated for the symptomatic treatment of moderate to severeidiopathic 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 than1,000 patients in Europe and the United States. These study resultshave confirmed that pramipexole provides rapid relief from symptomsafter just one week of starting treatment. Pramipexole is highlyefficacious at the starting dose of 0.125mg single dose per day andup to 0.75mg single dose per day[2] and is well tolerated[3],[4],[5].

The efficacy and tolerability of pramipexole in RLS continues tobe investigated in a comprehensive clinical trials programme withmore than 1,000 patients, to further assess the therapeutic potentialin this condition.

About Restless Legs Syndrome (RLS)

RLS is a neurological disorder characterised by an uncontrollableurge to move the legs, usually accompanied by unpleasant andsometimes painful sensations in the legs. RLS affects up to tenpercent of the population aged between 30 and 79 years[6] and aroundone-third of sufferers experience symptoms more than twice weeklycausing moderate to severe distress[7]. The motor-restlessnessworsens during the evening and night causing difficulty initiatingand maintaining sleep. The sleep disruption can lead to excessivedaytime sleepiness and compromise work performance. RLS also hasconsiderable impact on social activities that require immobility.

About pramipexole

Pramipexole, a compound from Boehringer Ingelheim research, iscurrently approved for the treatment of the signs and symptoms ofidiopathic Parkinson's Disease, as monotherapy or in combination withlevodopa. The most commonly reported adverse reactions in early andlate Parkinson's disease in clinical trials were dizziness,dyskinesia, headache, insomnia, somnolence, constipation, nausea,hallucinations visual, orthostatic hypotension and fatigue. Patientshave reported falling asleep without perceived warning signs duringactivities of daily living, including operation of a motor vehicle,which sometimes resulted in accidents. As also described in theliterature for antiparkinsonian dopamine replacement therapy, casesof behavioural changes have been reported.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leadingpharmaceutical companies. Headquartered in Ingelheim, Germany, itoperates globally with 144 affiliates in 45 countries and nearly36,000 employees. Since it was founded in 1885, the family-ownedcompany has been committed to researching, developing, manufacturingand marketing novel products of high therapeutic value for human andveterinary medicine.

In 2004, Boehringer Ingelheim posted net sales of 8.2 billion eurowhile spending nearly one fifth of net sales in its largest businesssegment Prescription Medicines on research and development.

For more information please visit www.boehringer-ingelheim.com

[1] Abetz L et al Evaluating the quality of life of patients withrestless legs syndrome Clin Ther 2004; 26(6) 925-935

[2]. Oertel W, Stiasny-Kolster K. Early and persistent effect ofpramipexole in RLS patients already with the starting dose. MovementDisorders 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: resultsof 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 largepolysomnographic study. Neurology 2004; 63 (8):1545

[5]. C. Trenkwalder, K. Stiasny-Kolster and the GermanRLS-Pramipexole Study Group. Sustained efficacy of Pramipexole inRestless Legs Syndrome. Sleep Med 2005; 6 (Suppl 2): S73

[6]. Phillips B et al Epidemiology of restless legs symptoms inadults Arch Intern Med 2000; 160(14): 2137-2141

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

ots Originaltext: Boehringer IngelheimIm Internet recherchierbar: http://www.presseportal.de

Contact:CONTACT: Ursula Bardon, Corporate Division Communications, BoehringerIngelheim GmbH, 55216 Ingelheim, Phone: +49-6132-77-2622, Fax: +49-6132-72-2622

Boehringer Ingelheim

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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)

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