Date: 2013-03-21
Type of information:
phase: 2
Announcement: presentation of results at American Academy of Neurology's Annual Meeting in San Diego
Company: Orion Corporation (Finland)
Product: ODM-101
Action mechanism: ODM-101 s a new levodopa product.
Disease: Parkinson's disease
Therapeutic area: Neurodegenerative diseases - CNS diseases
Country: Europe
Trial details:
Latest
news: * On March 21, 2013, Orion Corporation has presented Phase II data for its new levodopa product (ODM-101) at AAN Annual Meeting. According to this Phase II study, ODM-101 significantly decreased daily OFF-time without increasing ON-time with troublesome dyskinesias compared to reference product Stalevo®. 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®.
* On October 23, 2012, Orion has announced that ODM-101, a new levodopa product currently developed by the company 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.
Stalevo® is also a product of Orion's own pharmaceutical R&D.
