Levodopa dosing regimen
AssigneeAmneal Pharmaceuticals, LLC
InventorsRichard D'Souza, Hester Visser, Suneel Gupta
Life of this patent
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Abstract
The invention provides oral dosing regimens of controlled release levodopa compositions for use in treating patients with Parkinson's disease, primary parkinsonism/idiopathic parkinsonism, post-encephalitic parkinsonism, parkinsonism that may follow carbon monoxide intoxication, or parkinsonism that may follow manganese intoxication.
Claims21
A method for treating a patient diagnosed with Parkinson's disease comprising the oral administration of a controlled release dosage form comprising levodopa and a controlled release excipient and/or a muco-adhesive excipient;
- wherein the composition is administered twice a day with a starting dose comprising a total daily dose of levodopa of form is about 400 mg to about 1,400 mg;
- wherein the dose of levodopa administered each time is from the controlled release dosage form is from about 200 mg to about 700 mg, and wherein the patient prior to receiving the controlled release dosage form of levodopa was being treated with a total daily dose of about 500 mg or less of levodopa administered in three, four or more doses in a twenty-four hour period.
A method for treating a patient diagnosed with Parkinson's disease comprising the oral administration of a controlled release dosage form comprising levodopa and a controlled release excipient and/or a muco-adhesive excipient;
- the administration of the controlled release dosage form occurs every 6 to 12 hours and the patient exhibits:
- (i) a total “Off” time during a 24 hour period and/or or during waking hours in a 24 hour period of less than 5 hours.
A method for treating a patient diagnosed with Parkinson's disease comprising the oral administration of a controlled release dosage form comprising levodopa and a controlled release excipient and/or a muco-adhesive excipient;
- the administration of the controlled release dosage form occurs twice or thrice daily and the patient exhibits at least a 5% reduction in total “Off” time during waking hours compared to the patient receiving treatment with an immediate release levodopa and carbidopa oral dosage form administered five times a day.
Dependencies are inferred from the claim text.