Method for treatment of Parkinson's disease
Inventors
Birnberg, Tal • Adar, Liat • Perlstein, Itay
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11458115-B2
Publication Date
2022-10-04
Expiration Date
Abstract
Disclosed is a method for the treatment of a neurological or movement disorder, e.g., Parkinson's disease, in an individual in need thereof, by parenteral administration of levodopa and a dopa decarboxylase inhibitor (DDCI), such as carbidopa, benserazide or any combination thereof, concomitantly with oral administration of levodopa, a DDCI, such as carbidopa, benserazide, or any combination thereof.
Core Innovation
The invention relates to treating Parkinson’s disease in a patient in need thereof by parenteral administration of a levodopa component and a dopa decarboxylase inhibitor, including subcutaneous administration of a first pharmaceutical composition comprising a levodopa moiety and a carbidopa moiety. The subcutaneous administration is provided over a subcutaneous infusion time course of about 24 hours or more, and the levodopa moiety and carbidopa moiety are present in a ratio of between about 2:1 w/w to about 40:1 w/w.
The method further includes concomitantly administering levodopa by an oral route using at least one oral dosage form comprising levodopa before or during the subcutaneous infusion time course. The disclosure also includes converting the patient from administration of a previous form of levodopa to administration of at least one oral dosage form comprising levodopa, including an oral immediate release form, while concomitantly subcutaneously administering the levodopa and carbidopa composition.
The described approach addresses long or continuous subcutaneous infusion time courses in combination with oral levodopa dosing before or during the infusion. The partial content further describes pharmacokinetic synergism where the combined subcutaneous plus oral coadministration yields higher-than-expected levodopa exposure relative to additive effects from subcutaneous alone plus oral alone, while carbidopa exposure may be lower than expected.
Claims Coverage
The partial content includes four independent method claims. Across these, the core inventive coverage centers on subcutaneous infusion over about 24 hours or more of a levodopa/carbidopa composition while concomitantly administering oral levodopa dosage forms, and on conversion from a previous levodopa form to the oral levodopa regimen concurrent with the subcutaneous infusion.
Subcutaneous levodopa-carbidopa infusion with concomitant oral levodopa
Subcutaneously administering over a subcutaneous infusion time course of about 24 hours or more a first pharmaceutical composition comprising a levodopa moiety and a carbidopa moiety in a ratio of between about 2:1 w/w to about 40:1 w/w, and concomitantly administering, before or during the subcutaneous infusion time course, at least one oral dosage form comprising levodopa.
Converting to oral levodopa concurrent with subcutaneous levodopa-carbidopa infusion
Converting the patient from the administration of a previous form of levodopa to the administration of at least one oral dosage form comprising levodopa, subcutaneously administering over a subcutaneous infusion time course of about 24 hours or more a first pharmaceutical composition comprising a levodopa moiety and a carbidopa moiety, and concomitantly orally administering before or during the subcutaneous infusion time course the at least one oral dosage form comprising levodopa.
Converting to oral immediate release levodopa-carbidopa with subcutaneous infusion
Converting the patient from the administration of a previous form of levodopa to the administration of at least one oral immediate release form of levodopa-carbidopa, subcutaneously administering over a subcutaneous infusion time course of about 24 hours or more a first pharmaceutical composition comprising a levodopa moiety and a carbidopa moiety, and concomitantly orally administering before or during the subcutaneous infusion time course the at least one oral immediate release form of levodopa-carbidopa.
Oral before infusion during conversion to oral levodopa with subcutaneous infusion
Converting the patient from the administration of a previous form of levodopa to the administration of at least one oral dosage form comprising levodopa; subcutaneously administering over a subcutaneous infusion time course of about 24 hours or more a first pharmaceutical composition comprising a levodopa moiety and a carbidopa moiety; and concomitantly orally administering before the subcutaneous infusion time course the at least one oral dosage form comprising levodopa.
The claim set covers Parkinson’s disease treatment methods that combine subcutaneous infusion over about 24 hours or more of a levodopa/carbidopa composition with concomitant oral levodopa dosing, including conversion from a previous levodopa form to an oral dosage form. Quantitative embodiments further specify levodopa-to-carbidopa ratios, concentrations, and delivered levodopa amounts over the infusion duration, and narrow treatment to patient contexts such as motor fluctuations and advanced Parkinson’s disease.
Stated Advantages
Provides higher-than-expected plasma levodopa exposure when combined subcutaneous plus oral coadministration is used compared with additive effects from subcutaneous alone plus oral alone.
Supports long or continuous subcutaneous infusion time courses of about 24 hours or more in combination with oral levodopa dosage forms before or during the infusion.
Documented Applications
Treatment of Parkinson’s disease, including contexts narrowed to motor fluctuations and advanced Parkinson’s disease, using subcutaneous infusion over about 24 hours or more of a levodopa/carbidopa composition together with concomitant oral levodopa dosage forms.
Interested in licensing this patent?