EU approves new treatment for Parkinson's disease
An EU-wide marketing authorisation has been granted by the European Agency for the Evaluation of Medicinal Products (EMEA) for Stalevo, a new treatment developed by Finnish company Orion Pharma for Parkinson's Disease (PD).
An EU-wide marketing authorisation has been granted by the European Agency for the Evaluation of Medicinal Products (EMEA) for Stalevo, a new treatment developed by Finnish company Orion Pharma for Parkinson's Disease (PD).
Stalevo, which combines levodopa, carbidopa and entacapone in one tablet, represents the first new treatment for Parkinson's disease in three years, and the first new form of levodopa in more than a decade.
A US marketing authorisation for the product was received in June, and the product has already been launched there. Orion will introduce the product to the first European markets during the current quarter 2003. Orion expects Stalevo to become the leading product in its proprietary portfolio.
Levodopa is the most effective and widely used agent available for Parkinson's disease. Entacapone and carbidopa are enzyme-blocking compounds that enhance the therapeutic benefits of levodopa. Stalevo is indicated for patients with idiopathic PD who experience signs and symptoms of end-of-dose 'wearing off'.
'With Stalevo we can enhance the benefits of levodopa and more effectively treat the problems such as 'wearing off' that complicate the long-term use of levodopa and limit its utility. Stalevo thus represents an important advance in our ability to treat Parkinson's disease patients,' said Professor David Brooks, one of the leading Stalevo investigators, at the Medical Research Council Clinical Sciences Centre and Imperial College London, UK.
The effectiveness of levodopa, carbidopa and entacapone in the treatment of Parkinson's has been established in multi-centre, randomised, double blind placebo-controlled trials in patients experiencing "wearing off". The components of Stalevo were shown to increase the period where patients experience no symptoms and improve motor function and daily activities such as patients' ability to walk, dress, and maintain hygiene. In addition, in a separate study, most patients regarded Stalevo as easy to dose, use, handle and swallow.