Levodopa dosing regimen

1. A method for treating a levodopa naïve patient with Parkinson's disease comprising an oral administration of a controlled release levodopa dosage form comprising:

a) one or more controlled release components comprising levodopa, and a mucoadhesive polymer; and

b) one or more immediate release components comprising levodopa, and carbidopa; wherein the mucoadhesive polymer is a material capable of forming a positive ionic charge at pHs present in the human gastro-intestinal tract, wherein

the controlled release dosage form is administered twice a day with each dose administered each time comprising 140 mg of levodopa and a total daily administered levodopa dose of 280 mg;

wherein the patient is not being treated with a catechol-O-methyl transferase inhibitor and the patient has not been previously treated with levodopa;

wherein the twice a day dosing provides an improvement of at least 10% in the patient's tremor, dyskinesia, and/or mobility as measured by a Kinesia 360 Sensor;

wherein the one or more controlled release components are substantially free of carbidopa;

wherein the controlled release dosage form is free of a catechol-O-methyl transferase inhibitor; and

wherein the controlled release dosage form when tested using a USP Type I apparatus at 37° C.±0.5° C. with a rotational speed of 75 rpm and about 900 ml of simulated gastric fluid for 2 hours and pH 6.8 phosphate buffer thereafter, about 75% to about 100% of CD is released within 30 minutes; and about 15% to about 45% of LD is released within 30 minutes; wherein the simulated gastric fluid has a pH of from about 1 to about 4.0.

2. The method of claim 1 wherein after administration the controlled release dosage form provides a levodopa plasma level of at least about 300 ng/mL within about 1 hour after administration and after twice a day administration of the controlled release dosage form for at least 7 days provides a minimum levodopa plasma level at least about 250 ng/mL at about six hours after dosing.

3. The method of claim 2 , wherein after administration of the controlled release dosage form twice a day for at least 7 days, the minimum carbidopa plasma level is at least about 40 ng/mL seven to eight hours after dosing.

4. The method of claim 1 wherein the patient is newly diagnosed with Parkinson's disease.

5. A method for treating a levodopa naïve patient with Parkinson's disease comprising an oral administration of a controlled release levodopa dosage form comprising: a) one or more controlled release components comprising levodopa, and a mucoadhesive polymer; and

b) one or more immediate release components comprising levodopa and carbidopa;

wherein the mucoadhesive polymer is a material capable of forming a positive ionic charge at pHs present in the human gastro-intestinal tract,

wherein the controlled release dosage form is administered twice a day with each dose administered each time comprising 140 mg of levodopa and a total daily administered levodopa dose of 280 mg,

wherein the patient is not being treated with a catechol-O-methyl transferase inhibitor and the patient has not been previously treated with levodopa;

wherein twice a day dosing improves the patient's motor state as determined by patient's Parkinsons disease diary;

wherein the one or more controlled release components are substantially free of carbidopa;

wherein the controlled release dosage form is free of a catechol-O-methyl transferase inhibitor;

and wherein the controlled release dosage form when tested using a USP Type I apparatus at 37° C.±0.5° C. with a rotational speed of 75 rpm and about 900 ml of simulated gastric fluid for 2 hours and pH 6.8 phosphate buffer thereafter, about 75% to about 100% of CD is released within 30 minutes; and about 15% to about 45% of LD is released within 30 minutes; wherein

the simulated gastric fluid has a pH of from about 1 to about 4.0.

6. A method for treating a levodopa naïve patient with Parkinson's disease comprising an oral administration of a controlled release levodopa dosage form comprising: a) one or more controlled release components comprising levodopa, and a mucoadhesive polymer; and

b) one or more immediate release components comprising levodopa and carbidopa;

wherein the mucoadhesive polymer is a material capable of forming a positive ionic charge at the pHs present in the human gastro-intestinal tract,

wherein the controlled release dosage form is administered twice a day with each dose administered each time comprising 140 mg of levodopa and a total daily administered levodopa dose of 280 mg,

wherein the patient is not being treated with a catechol-O-methyl transferase inhibitor and has not been previously treated with levodopa;

wherein the twice a day dosing reduces the patient's Movement Disorders Society version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores by at least 3 points; and

wherein the one or more controlled release components are substantially free of carbidopa;

wherein the controlled release dosage form is free of a catechol-O-methyl transferase inhibitor;

and wherein the controlled release dosage form when tested using a USP Type I apparatus at 37° C.±0.5° C. with a rotational speed of 75 rpm and about 900 ml of simulated gastric fluid for 2 hours and pH 6.8 phosphate buffer thereafter, about 75% to about 100% of CD is released within 30 minutes; and about 15% to about 45% of LD is released within 30 minutes; wherein

the simulated gastric fluid has a pH of from about 1 to about 4.0.

7. The method of claim 6 wherein the twice a day dosing reduces the patient's MDS-UPDRS scores from about 3 points to about 15 points.

8. The method of claim 5 wherein after administration the controlled release dosage form provides a levodopa plasma level of at least about 300 ng/ml within about 1 hour after administration and after twice a day administration of the controlled release dosage form for at least 7 days provides a minimum levodopa plasma level at least about 250 ng/mL six hours after dosing.

9. The method of claim 6 wherein after administration the controlled release dosage form provides a levodopa plasma level of at least about 300 ng/ml within about 1 hour after administration and after twice a day administration of the controlled release dosage form for at least 7 days provides a minimum levodopa plasma level at least about 250 ng/mL six hours after dosing.

10. The method of claim 1 , wherein the Parkinson's disease comprises primary parkinsonism.

11. The method of claim 1 , wherein the twice-a-day administration provides a reduction of from about 10%-40% in the patient's tremor, dyskinesia, and/or mobility as measured by a Kinesia 360 Sensor.

12. The method of claim 5 , wherein the Parkinson's disease comprises primary parkinsonism.

13. The method of claim 5 , wherein the twice-a-day dosing improves patient's motor state by at least 10%.

14. The method of claim 6 , wherein the Parkinson's disease comprises primary parkinsonism.