Orion Pharma and Novartis launch first Parkinson's disease study to explore potential of delaying motor complications with Stalevo®

Orion Pharma and Novartis announced that they are launching STRIDE-PD (STalevo Reduction In Dyskinesia Evaluation). This major study in Parkinson's disease (PD) seeks to investigate if, when used as initial therapy, the optimized levodopa medication Stalevo - containing levodopa, carbidopa and entacapone - delays the onset of motor complications, such as dyskinesias, compared to traditional formulation of levodopa/carbidopa.

 

 

STRIDE-PD will enroll approximately 740 patients at 70 centres in 14 countries: Austria, Belgium, Canada, France, Finland, Germany, Greece, Italy, Spain, Sweden, Turkey, Switzerland, the United Kingdom and the United States of America. Patient recruitment has started in September and is estimated to continue for 12 months. The first study results are expected in 2007.

 

Patients with PD between 30 and 70 years of age who have been diagnosed within the last five years prior to study initiation and who require the start of levodopa therapy to manage their symptoms may be eligible to participate in this two-year study.

 

 "The importance of the STRIDE-PD study could be major. If the study shows that Stalevo is superior to traditional levodopa/carbidopa therapy in the time to onset of dyskinesias, this could change the current treatment paradigm completely," said Werner Poewe, Chair of the Department of Neurology at Innsbruck University, Austria. "We would then use Stalevo from the very first day in patients needing levodopa treatment."

 

Levodopa is the most effective and most widely used symptomatic PD treatment and has remained the "gold standard" of care for nearly 40 years. The vast majority of people with PD eventually require levodopa treatment to control their symptoms, even if they begin their therapy with another drug. However, after several years of treatment with levodopa, patients often begin to experience motor complications, such as "wearing-off" (when the effect of one dose of medication doesn't last until the next scheduled dose) and dyskinesias.

 

Characterized by abnormal and involuntary movements, dyskinesias are a major challenge for people with PD since they can result in fragmented or jerky motions that are different from the rhythmic tremor commonly associated with PD.

 

"We are very excited about the launch of STRIDE-PD. Dyskinesias often become a serious problem for people with PD. Delaying the onset of these motor complications would therefore offer a real improvement in the quality of life for patients and their families," said Mary Baker, President of the European Parkinson's Disease Association (EPDA), United Kingdom.

 

For further information on STRIDE-PD, please also refer to www.epda.eu.com.

 

Stalevo (levodopa, carbidopa and entacapone) is a new and optimized levodopa product with a longer duration of action compared to traditional levodopa/carbidopa preparations.

 

Stalevo tablets are currently indicated for certain PD patients who are experiencing "wearing-off" motor complications.  In patients with "wearing-off," clinical trials have shown that the addition of entacapone to levodopa/carbidopa can significantly extend the duration of benefit of each medication dose and enhance the PD patients' ability to control body movements and perform basic functions, such as walking and dressing. 

The most common side effects of Stalevo therapy are dopaminergic in nature (e.g. dyskinesia, nausea.)  These side effects may be manageable with alteration in the drug dosing schedule.  Other common side effects include diarrhea, hyperkinesias, urine discoloration, hypokinesia, abdominal pain, dizziness, constipation, fatigue, pain and hallucinations. 

Stalevo, developed by Orion Pharma, is marketed by Novartis and Orion Pharma in their respective territories. Stalevo is available in Austria, Belgium, Brazil, Denmark, Iceland, Ireland, Finland, France, Germany, Greece, Luxemburg, the Netherlands, Norway, Spain, Sweden, Switzerland, the United Kingdom and the United States.

PD is a chronic and progressive neurological condition that affects 6.3 million people worldwide. One percent of people over the age of 60 and two percent of people over the age of 80 suffer from this disease.

 

While their cause is unknown, PD symptoms are primarily the result of a degeneration of dopaminergic cells, or neurons, in the substantia nigra, a part of the brain that controls and modulates movement.

 

Symptoms include limbs that tremble, slowness of movement, stiffness and rigidity of limbs and gait or balance problems. As the disease progresses, these symptoms usually increase and impact a person's ability to work and function.

 

Orion Pharma, the originator of entacapone and Stalevo, is a research and development-orientated pharmaceutical division of the Orion Group (HEX:ORNAS, ORNBS) and one of the leading companies in the healthcare sector in the Nordic area of Europe. Pharmaceutical R&D at Orion Pharma focuses on three core therapy areas: CNS therapies, cardiology and critical care, and hormonal therapies. Entacapone, a COMT enzyme inhibitor used in the treatment of Parkinson's disease, is one of Orion Pharma's patented molecule discoveries. It is available globally as Comtess and Comtan, and as one of the three active compounds in the novel levodopa treatment, Stalevo. For further information please consult http://www.orion.fi.

 

Orion Pharma R&D Clinical Development

Phone +358 10 429 7667 (direct)

Mobile phone +358 50 429 7667

juha.ellmen@orionpharma.com