Boehringer Ingelheim's prolonged-release Mirapexin/Sifrol gets EU clearance for Parkinson's disease

Independent German drug major Boehringer Ingelheim's Mirapexin/Sifrol (pramipexole) new prolonged-release, once daily tablet has been granted marketing authorization by the European Commission in all European Union/European Economic Area  countries for the treatment of early and advanced idiopathic Parkinson's disease.

Pramipexole, also used in the treatment of restless legs syndrome, generated revue of 752 million euros ($1.11 billion) for the company in 2008, up 21% on the previous year.

The new EU 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.

'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 Manfred Haehl, 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.'