Orion seeks broader Stavelo indication

Orion has announced that it has started the regulatory processes in Europe and the US for the seeking of an expanded indication for Stavelo (levodopa, carbidopa, entacapone).

The company has taken these steps following favourable results of the First-Step phase III clinical study in patients with Parkinson’s disease.

Orion hopes to extend the indication of the compound to include early-stage patients whose condition requires the initiation of treatment with levodopa.

Stavelo is an enhanced levodopa therapy that contains both the DDC inhibitor carbidopa and COMT inhibitor entacapone to prevent the breakdown of levodopa and provide patients with a more continuous supply of the drug to the brain.

The compound has been shown to provide enhanced symptom control throughout the day when compared to levodopa and carbidopa.

At present, Stavelo is indicated for advanced Parkinson’s disease patients experiencing “wearing-off”- end-of-dose moor fluctuations.

“Orion Corporation will provide an update of the progress of the review process primarily in its quarterly financial reviews,” the company said.

The key results of the First Step study will be published later today by Novartis, the marketing partner for the compound and sponsor of the study.

In January 2008, test results from Novartis and Orion revealed that patients treated with Stavelo recorded higher scores on motor function and daily living activity tests than those receiving the standard treatment.