First Approval, In USA, For P&U/Boehringer Ingelheim's Mirapex

Beohringer Ingelheim and Pharmacia & Upjohn have received marketingclearance from the US Food and Drug Administration for Mirapex (pramipexole dihydrochloride), a non-ergot dopamine D2/D3 agonist for the treatment of patients with idiopathic early or advanced Parkinson's disease (the latter in combination with levodopa). This is the first approval for the drug worldwide, and is the first new Parkinson's drug to be cleared by the FDA since 1989.

In a randomized dose-ranging study of the safety and efficacy of pramipexole in early Parkinson's disease, published in the Journal of the American Medical Association (July 9), a total of 264 patients were involved. Patients were defined as eligible if they had had idiopathic Parkinson's disease for less than seven years, if they did not require treatment with levodopa or dopamine agonists, and had not taken any medication for the three months leading up the trial. In addition, patients must have been in stages I, II or III on the Hoehn and Yahr scale, indicating mild-to-moderate Parkinson's, at the start of the study.

Patients were randomized to receive pramipexole 1.5mg/day, 3mg/day, 4.5mg/day, 6mg/day or matching placebo, and were titrated up to the target dose over a period of six weeks. Once at the target dose, treatment was continued for a further four weeks, followed by a one-week discontinuation period.