Boehringer Ingelheim receives European approval for two new strengths for the once daily tablet formulation of Mirapexin®/Sifrol® prolonged-release for the treatment of Parkinson’s disease

Ingelheim, Germany, 14 June 2010 – Boehringer Ingelheim today announced the European approval of two new tablet strengths (2.25 mg and 3.75 mg) of the Mirapexin®/Sifrol® (pramipexole) prolonged-release, once daily formulation for the treatment of early and advanced idiopathic Parkinson’s disease (PD).¹ The new dosages will now make it possible for PD patients to take only one Mirapexin®/Sifrol® tablet once a day, thereby further reducing the number of pills taken each day. This may increase compliance and may improve Parkinson’s disease patients’ quality of life.

The new dosing formulations will also offer an efficacy and safety profile comparable to the immediate release tablet taken three times daily as demonstrated in the studies which lead to the European Commission’s recent approval of the prolonged-release formulation.^2-7

“Following the once daily prolonged-release approval of Mirapexin®/Sifrol®, both in Europe and more recently in the USA, we are pleased to now make available truly once daily options as one tablet for Parkinson’s disease patients, many of whom have a multitude of medications to take on a daily basis,” said Prof Klaus Dugi, MD, Corporate Senior Vice President Medicine at Boehringer Ingelheim Corporate Headquarters“It is hoped that the new dosing formulations will further contribute to reducing the pill burden and aiding compliance both for patients and their carers,”

Furthermore a 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.^8,9
“Most people with Parkinson’s disease take many different pills on a daily basis, to manage their PD symptoms and other concomitant conditions,” said Professor Angelo Antonini Director of the Parkinson Unit at the Research Institute IRCCS San Camillo Venice, Italy. “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.”

Following the marketing authorisation by the European Commission in October 2009, a once daily, extended release formulation of pramipexole (marketed under the trade name Mirapex ER® in the U.S.A.) was granted market authorisation in 2010 by the U.S. Food and Drug Administration (FDA) for the treatment of early (in February 2010) and advanced (in March 2010) Parkinson’s disease.^10,11

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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.^12-16 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 90 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 142 affiliates in 50 countries and more than 41,500 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 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of net sales in its largest business segment Prescription Medicines on research and development.

Related links:
Further information on Parkinson’s disease and pramipexole can be found at News Topic Parkinson's Disease and www.youtube.com/user/parkinsonsmatters.