Promising Phase II Data For New Parkinson's Disease Drug Presented
22 Mar 2013 A new levodopa product (ODM-101) developed by Orion Corporation could improve the treatment of advanced Parkinson's disease patients. According to a Phase II study, presented yesterday at American Academy of Neurology's Annual Meeting in San Diego, ODM-101 significantly decreased daily OFF-time without increasing ON-time with troublesome dyskinesias compared to reference product Stalevo®, which is an established standard medication for advanced Parkinson's patients experiencing so-called end-of-dose wearing off symptoms associated with levodopa therapy. Stalevo, also a product of Orion's own pharmaceutical R&D, contains three active substances in one tablet: levodopa and the enzyme inhibitors entacapone and carbidopa. ODM-101 has the same components as Stalevo but with higher and fixed amount of carbidopa (either 65 or 105 mg) regardless of levodopa dosage. For the clinical Phase II trial, 117 patients with Parkinson's disease and with response fluctuations were randomly given Stalevo, ODM-101/65 mg and ODM-101/105 mg in a cross-over study with three periods each lasting for 4 weeks. Daily OFF-time (time when patients do not have adequate response to their treatment) and ON-time (time when patients have a good treatment response) with and without troublesome dyskinesia (involuntary movements) were measured by patient diary. Both ODM-101/65 mg and ODM-101/105 mg reduced daily OFF-time from baseline more than Stalevo. There was significant carry-over effect (p=0.048) and therefore pre-planned carry-over adjusted OFF-times were analysed. Both ODM-101 combinations decreased the carry-over adjusted OFF-time significantly more compared to Stalevo, the reductions being 1.53 hours for ODM-101/65 mg (p= 0.02 vs Stalevo), 1.57 hours for ODM-101/105 mg (p=0.01 vs Stalevo) and 0.91 hours for Stalevo. Similarly, both ODM-101 combinations increased the carry-over adjusted ON-time without troublesome dyskinesia significantly more compared to Stalevo. There were no significant differences between the treatments in ON-time with troublesome dyskinesia or in UPDRS II and III scores. Overall, tolerability and safety of ODM-101 was comparable to Stalevo. Dr Reijo Salonen, Senior Vice President of R&D at Orion commented:
"Our organization has a long commitment to improving the lives of people with
Parkinson's Disease. These results indicate that ODM-101 can further extend the 'ON
time' that is so important in the daily life of a patient suffering from this devastating
illness. I am pleased and proud of the scientists and clinicians who have worked so
diligently to achieve this important milestone".
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.
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Orion. (2013, March 22). "Promising Phase II Data For New Parkinson's Disease Drug
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