ODM-101, a new levodopa product currently developed by Orion for the treatment of Parkinson’s disease, has successfully completed Phase II Proof of Concept trial. The key results indicate that ODM-101 was more efficacious than the reference product Stalevo® in the treatment of advanced Parkinson’s disease patients. The study included more than 100 patients in Europe.
Professor Claudia Trenkwalder, the Principal Investigator of the ODM-101 Proof of Concept study, comments:
“This phase II study demonstrated that ODM-101 has potential to be significantly more effective than Stalevo in the daily treatment of Parkinson’s disease patients with response fluctuations. ODM-101 reduced time periods during the day when patients do not have adequate treatment response. These benefits were possible without an increase in troublesome involuntary movements (dyskinesia).”
Stalevo, a product of Orion’s own pharmaceutical R&D, has been established by long-term clinical practice as a standard medication for advanced Parkinson’s patients experiencing so-called end-of-dose wearing-off symptoms associated with levodopa therapy. Stalevo is an enhanced levodopa treatment containing three active substances in one tablet: levodopa and the enzyme inhibitors entacapone and carbidopa. Measured in overall sales of entacapone products in 2011, Orion is the world’s leading manufacturer of Parkinson’s drugs (IMS Health 2012)
About Parkinson’s disease
Symptoms typical of Parkinson’s disease, such as slowness of movements and tremor, are caused by the brain’s inability to produce enough dopamine, a neurotransmitter important for the body’s motor functions. Levodopa is the natural precursor of dopamine and thus the standard drug used in the treatment of Parkinson’s symptoms. When used alone, most of levodopa is metabolised in the body before it reaches the brain. Enzyme inhibitors such as entacapone have thus been developed to enhance the effect of levodopa. An unmet medical need has however been identified for novel and even more effective levodopa treatments.
Typically when initiating the treatment with levodopa the patient’s symptoms remain under control during the entire day. This period of good response is often referred to as “honeymoon”. As the disease progresses, however, the action of levodopa gradually wears off and its improving effect becomes more irregular.