Orion's Stalevo fails to delay dyskinesia in early PD trial

Orion's Stalevo (levodopa, carbidopa and entacapone) missed the primary endpoint in a trial of 747 patients with early Parkinson's disease  requiring levodopa treatment.

The agent did not delay the onset of involuntary movements (dyskinesia)  associated with wearing off of levodopa. The study was aimed at  supporting the extension of the current European Union indication to  early Parkinson's.

Stalevo is currently indicated for the treatment of adult patients with  the disease and end-of-dose motor fluctuations not stabilized on  levodopa/dopa decarboxylase inhibitor treatment. Applications for  extending the indication of Stalevo to patients requiring initiation of  levodopa therapy are already under review by the European Medicines  Agency (EMEA) and the US Food and Drug Administration, based on the  favorable results from FIRST-STEP, a study conducted in North America  and Europe by Novartis, Orion's marketing partner.