Methods for treatment of parkinson's disease
Inventors
Fariello, Ruggero • Cattaneo, Carlo • Salvati, Patricia • Benatti, Luca
Assignees
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Publication Number
US-8283380-B2
Publication Date
2012-10-09
Expiration Date
Abstract
New uses of safinamide, safinamide derivatives and MAO-B inhibitors in novel types of treatment for Parkinson's Disease are described. More specifically, the invention relates to methods for treating Parkinson's Disease through the administration of safinamide, a safinamide derivative, or a MAO-B inhibitor, in combination with other Parkinson's Disease agents or treatments, such as levodopa/PDI or dopamine agonists.
Core Innovation
The invention relates to methods of treating idiopathic Parkinson’s disease in a patient by concurrently administering safinamide, or a pharmaceutically acceptable salt thereof, to a patient receiving a stable dose of levodopa. The safinamide is administered on an oral dosage schedule of about 0.5 mg/kg/day to about 5 mg/kg/day while maintaining the patient on the stable levodopa dose.
The disclosure further defines safinamide derivatives as compounds of Formula I with specified substituent definitions. It describes safinamide and safinamide derivatives, including MAO-B inhibitors, as usable in combination with other Parkinson’s disease therapies, such as levodopa/PDI and other adjunct therapies.
The disclosure reports unexpected synergistic benefits of combination therapy compared with single-agent treatment, including the add-on effect when patients are maintained on stable dopamine agonists. The document includes evidence for safinamide, including rodent/primates neuroprotection and a randomized double-blind placebo-controlled Phase II trial in early idiopathic Parkinson’s disease, with improvement assessed using Unified Parkinson’s Disease Rating Scale (UPDRS) Part III responder endpoints and summarized safety and adverse-event outcomes.
Claims Coverage
The provided claim set contains two independent claims, both centered on treating idiopathic Parkinson’s disease with concurrent levodopa and safinamide administered on an oral dosage schedule within a specified range. The independent claims differ in that one explicitly frames the improvement while maintaining a stable levodopa dose and the other frames the overall method as administering therapeutically effective stable levodopa together with safinamide.
Stable levodopa with concurrent safinamide dosing range
A method of treating idiopathic Parkinson's disease in a patient receiving a stable dose of levodopa, comprising concurrently administering safinamide, or a pharmaceutically acceptable salt thereof, on an oral dosage schedule of about 0.5 mg/kg/day to about 5 mg/kg/day while maintaining the patient on a stable dose of levodopa.
Therapeutically effective stable levodopa concurrently with safinamide
A method of treating idiopathic Parkinson's Disease comprising administering a therapeutically effective stable dose of levodopa; and concurrently administering safinamide, or a pharmaceutically acceptable salt thereof, on an oral dosage schedule of about 0.5 mg/kg/day to about 5 mg/kg/day.
Across the independent claims, the main inventive concept is concurrent administration of safinamide (or a pharmaceutically acceptable salt) on an oral dosing schedule of about 0.5 mg/kg/day to about 5 mg/kg/day to a patient while administering and maintaining levodopa as a stable, therapeutically effective dose.
Stated Advantages
Unexpected synergistic benefits of combination therapy over single-agent treatment.
Add-on effect in patients on stable dopamine agonists.
Superiority for safinamide 1.0 mg/kg versus placebo in overall responder rate in the summarized Phase II trial.
Documented Applications
Treatment of idiopathic Parkinson’s disease using safinamide or safinamide derivatives (including MAO-B inhibitors) in combination with other Parkinson’s disease therapies such as levodopa/peripheral decarboxylase inhibitor and optional adjunct therapies.
Use in a randomized double-blind placebo-controlled Phase II trial in early idiopathic Parkinson’s disease assessing UPDRS Part III responder endpoints.
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