Boehringer gets OK to sell extended-release Parkinson's drug

Boehringer Ingelheim has received the go-ahead in Europe to sell a once-daily version of its Parkinson’s disease drug Mirapexin.

The European Commission has granted marketing approval for prolonged-release Mirapexin/Sifrol(pramipexole), a once-daily tablet for the treatment of early and advanced idiopathic Parkinson's disease. The approval was based on data showing that the new formulation can offer an efficacy and safety profile comparable to the immediate release tablet which is taken three times daily.

Boehringer noted that a further trial has shown that patients already taking Mirapexin may easily be switched overnight to the prolonged-release tablet, at the same daily dose. The new formulation causes less frequent fluctuations in the plasma concentration over 24 hours compared to the three-times daily drug, “an important aspect for physicians when choosing the best treatment option for their patient," said the company’s senior vice president of medicine, Manfred Haehl.

Boehringer quoted Mary Baker, president of the European Federation of Neurological Associations, as saying that most people with Parkinson's disease take many different pills on a daily basis, to manage their symptoms and other concomitant conditions. “Being able to reduce their pill burden without foregoing the effectiveness…can improve patient adherence to their treatment regimen," she added.

The extended-release formulation of pramipexole is currently under review with the US Food and Drug Administration.