Positive primary endpoint from FIRST-STEP study with Stalevo in early Parkinson's Disease
Orion Corporation has been informed by its marketing partner Novartis about the positive outcome of FIRST-STEP, a Phase 3 clinical study conducted by Novartis in 423 patients with early Parkinson's Disease (PD). The aim of the study was to determine whether treatment with Stalevo, an Orion-originated levodopa treatment (levodopa/carbidopa/entacapone) provides better symptomatic benefit than the standard levodopa/carbidopa in early PD.
The FIRST-STEP study was sponsored by Novartis and conducted in the USA, Canada and six other countries in 2005-2007. The patients were randomised to receive three daily doses of either Stalevo or levodopa/carbidopa, each containing 100 mg of the active drug, levodopa. Each patient received treatment for 9 months. The primary end-point of the study was the change from baseline in combined UPDRS (Unified Parkinson's Disease Rating Scale) part II and III scores measuring activities of daily living and motor function in patients with PD. The treatment difference was statistically significant (p<0.05) in favour of Stalevo.
Stalevo (levodopa/carbidopa/entacapone) is an enhanced levodopa therapy for the treatment of Parkinson's Disease indicated for those patients experiencing wearing-off motor complications. Stalevo contains both a DDC inhibitor (carbidopa) and a COMT inhibitor (entacapone) that prevent the breakdown of levodopa and so provide a more continuous supply of levodopa to the brain. Stalevo provides enhanced symptom control throughout the day vs. traditional levodopa and the efficacy of Stalevo is maintained during long-term treatment. Stalevo, developed by Orion Corporation, is marketed by Novartis and Orion in their respective territories.
Orion is dedicated to treating and preventing disease by discovery and developing innovative medicinal treatments. In 2006, Orion generated sales of EUR 641.1 million, invested EUR 84.1 million in research and development and employed approximately 3,060 people Orion corporate headquarters are in Espoo, Finland. For more information, please visit: http://www.orion.fi/english/.
Reijo Salonen Olli Huotari
Senior VP, Research and Development Senior VP, Corporate Functions
Reijo Salonen, Senior VP, Research and Development, phone +358 10 426 3647
Orionintie 1A, FI-02200 Espoo