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European Scientific Committee Positive Recommendation From For A New Once Daily Mirapexin(R) Formulation For The Treatment Of Parkinson's Disease

Article Date: 28 Jun 2009
http://www.medilexicon.com/medicalnews.php?newsid=155570

Boehringer Ingelheim announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending the approval of a once daily formulation for Mirapexin®/ Sifrol® (pramipexole), in all countries of the European Union, Norway, Iceland and Liechtenstein. The CHMP recommendation states that the new prolonged-release formulation is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on off" fluctuations).

The CHMP recommendation follows clinical trial results confirming the high therapeutic benefits of Mirapexin® / Sifrol® also when administered in a convenient once-a-day formulation.1-4