Stalevo misses dyskinesia endpoint in early PD

Orion (HSE:ORNAV; HSE:ORNBV) said Stalevo levodopa/carbidopa/entacapone missed the primary endpoint in the Phase III STRIDE-PD trial to treat early Parkinson's disease. In the international trial in 747 patients requiring the start of levodopa therapy, onset of dyskinesia occurred significantly sooner in patients given Stalevo than in patients given levodopa/carbidopa.

Applications seeking to expand Stalevo's label to include patients new to levodopa therapy are under review at FDA and EMEA, based on a prior Phase III trial that showed superiority to levodopa/carbidopa on change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III scores. The company has begun the process of evaluating the new data with the regulators. ...