Boehringer Ingelheim receives approval from the European Commission for Mirapexin®/Sifrol® prolonged-release, once daily table

Boehringer Ingelheim receives approval from the European Commission for Mirapexin®/Sifrol® prolonged-release, once daily tablet for the treatment of Parkinson's disease

New formulation brings the established efficacy of Mirapexin®/Sifrol® to patients with Parkinson`s disease in the convenience of a once daily dose

14  October 2009
For medical media, outside the US only

Ingelheim/Germany, 14 October 2009 - Boehringer Ingelheim today announced that the Mirapexin®/Sifrol® (pramipexole) new prolonged-release, once daily tablet has been granted marketing authorisation by the European Commission in all EU/EEA*) countries for the treatment of early and advanced idiopathic Parkinson's disease (PD). The approval was based on the submission of clinical trial results showing that the new formulation can offer an efficacy and safety profile comparable to the immediate release tablet taken three times daily.1-6

In addition to clinical trial results that confirm the important therapeutic benefits of the new formulation when administered in a convenient once-a-day regimen, a further trial has shown that patients already taking Mirapexin®/Sifrol® immediate release tablets may easily be switched overnight to the Mirapexin®/Sifrol® prolonged-release tablet, at the same daily dose.7,8

"The European approval of the new formulation marks another big step in meeting patients' needs and represents a milestone for this worldwide highly successful treatment for Parkinson's disease. We are very pleased that due to the robust evidence base, the regulatory review experienced no delay, which will allow the first European countries to already make the once daily tablet available to patients," said Dr. Manfred Haehl, MD, Senior Vice-President Medicine at Boehringer Ingelheim Corporate Headquarters. "In addition, the data show that the prolonged-release Mirapexin®/Sifrol® tablet causes less frequent fluctuations in the plasma concentration over 24 hours compared to the three times daily administration of the immediate release tablet, an important aspect for physicians when choosing the best treatment option for their patient."

Mary Baker, MBE, President of the European Federation of Neurological Associations (EFNA) commented on the European approval of the new formulation: "Most people with Parkinson's disease take many different pills on a daily basis, to manage their PD symptoms and other concomitant conditions. Being able to reduce their pill burden without foregoing the effectiveness will be welcomed by patients as well as by their care givers as it is expected that a once-daily administration can improve patient adherence to their treatment regimen."

A new drug application (NDA) for a once daily, extended release formulation of pramipexole (marketed under the trade name Mirapex® in the U.S.A.) is in review with the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson's disease (currently available in the U.S.A. as immediate release formulation).

Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.

Notes to Editor:
About Parkinson's disease (PD)
Parkinson's disease is the second most common chronic neurological disorder in older adults after Alzheimer's. Its worldwide prevalence is estimated to be approximately one to two percent of those over 65 years.9-13 Although traditionally PD is associated with motor symptoms (such as tremor, rigidity, slowed motion, imbalance, shuffling gait, loss of facial expression), the non-motor symptoms, including depressive symptoms, pain, cognitive impairment and sleep disorders can be significant. Symptoms can vary from patient to patient, but worsen over time.

About Mirapexin®/Sifrol® (pramipexole)
Pramipexole (known under the trade names Mirapexin®, Sifrol®, Mirapex® and Pexola®) is a compound from Boehringer Ingelheim research first approved in 1997 and to date available in over 70 countries across the globe for the treatment of the signs and symptoms of early and advanced idiopathic Parkinson`s disease, as monotherapy or in combination with levodopa. In October 2009, pramipexole received approval by the European Commission for its new prolonged-release, once daily tablet for the treatment of early and advanced Parkinson's disease. Pramipexole (immediate release formulation) is also indicated since 2006 for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS).

The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson's disease treated with pramipexole were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.

Pramipexole may cause patients, particularly with Parkinson's disease, to fall asleep without any warning even while doing normal daily activities such as driving. When taking pramipexole hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up.

Patients and caregivers should be aware of the fact that abnormal behaviour (reflecting symptoms of impulse control disorders and compulsive behaviours) such as binge eating, compulsive shopping, hypersexuality and pathological gambling have been reported in patients treated with dopaminergic drugs, including pramipexole. Dose reduction/tapered discontinuation should be considered.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 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 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

*all 27 Member States of the European Union plus Norway and Iceland


Related links: Parkinson`s disease and Mirapexin® / Sifrol® (pramipexole)
ParkinsonsMatters BI YouTube channel


References:
1 Hauser R et al. Double-blind evaluation of pramipexole extended-release (ER) in early Parkinson's disease. Abstract S43.003 presented on 30 April 2009 at AAN 61st Annual Meeting, Seattle, USA.
2 Salin L et al. Double-blind evaluation of maintenance of efficacy of pramipexole extended-release in early Parkinson's disease. Abstract P06.150 presented on 29 April 2009 at AAN 61st Annual Meeting, Seattle, USA.
3 Poewe, W et al. Pramipexole Extended-Release is Effective in Early Parkinson's Disease. Poster We-185. (presented at MDS International Congress, Paris, France, 10 June 2009).
4 Schapira, A et al. Efficacy and safety of pramipexole extended-release for advanced Parkinson's disease. Poster We-199 (presented at MDS International Congress, Paris, France.
5 Poewe W et al. 33-week non-inferiority of extended- vs immediate-release pramipexole tablets in treatment of early Parkinson's disease. Platform presentation (abstract SC202) presented on 14 September 2009 at 13th EFNS Congress, Florence, Italy.
6 Schapira A et al. Decrease in off-time for extended- and for immediate-release pramipexole in advanced Parkinson's disease. Platform presentation (abstract SC203) presented on 14 September 2009 at 13th EFNS Congress, Florence, Italy.
7 Rascol O et al. Overnight switching from immediate- to extended-release pramipexole in early Parkinson's disease. Abstract P06.152 presented on 29 April 2009 at AAN 61st Annual Meeting, Seattle, USA.
8 Rascol O et al. Dosage, safety, and tolerability for overnight switching from immediate- to extended-release pramipexole in early Parkinson's disease. Platform presentation (abstract SC205) presented on 14 September at 13th EFNS Congress, Florence, Italy.
9 Tandberg E et al. The occurrence of depression in Parkinson`s disease. Arch Neurol 1996; 53(2): 175-179.
10 Zhang ZX et al. Worldwide occurrence of Parkinson`s disease: An updated review. Neuroepidemiology 1993; 12: 195-208.
11 Van Den Eeden SK et al. Incidence of Parkinson`s disease: variation by age, gender, and race/ethnicity. Am J Epidemiol 2003; 157: 1015-22.
12 Nussbaum R et al. Alzheimer's disease and Parkinson's disease. N Engl J Med 2003;348:1356-64.
13 de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol 2006;5:525-35.

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