Method for Treating a Restless Limb Disorder
First Claim
1. A method for treating a restless limb disorder in a subject, comprising administering, transmucosally in the oronasopharyngeal chamber of the subject, one or more doses of rotigotine or a pharmaceutically acceptable salt, prodrug or metabolite thereof, wherein each such dose comprises an amount effective to reduce occurrence and/or severity of one or more symptoms of the disorder, but wherein the total of all such doses in a 24-hour period does not exceed about 450 μ
- g rotigotine free base equivalent.
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Accused Products
Abstract
A method for treating a restless limb disorder such as restless legs syndrome in a subject comprises administering, transmucosally in the oronasopharyngeal chamber of the subject, one or more doses of rotigotine or a pharmaceutically acceptable salt, prodrug or metabolite thereof, wherein each such dose comprises an amount effective to reduce occurrence and/or severity of one or more symptoms of the disorder, but wherein the total of all such doses in a 24-hour period does not exceed about 450 μg rotigotine free base equivalent.
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Citations
52 Claims
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1. A method for treating a restless limb disorder in a subject, comprising administering, transmucosally in the oronasopharyngeal chamber of the subject, one or more doses of rotigotine or a pharmaceutically acceptable salt, prodrug or metabolite thereof, wherein each such dose comprises an amount effective to reduce occurrence and/or severity of one or more symptoms of the disorder, but wherein the total of all such doses in a 24-hour period does not exceed about 450 μ
- g rotigotine free base equivalent.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. A pharmaceutical article comprising (a) a reservoir containing a composition that comprises, in a pharmaceutically acceptable vehicle, rotigotine or a pharmaceutically acceptable salt, prodrug or metabolite thereof in an amount providing one or more doses;
- and (b) indicia, on the reservoir or in or on packaging thereof, for oronasopharyngeal administration of said one or more doses in an amount not exceeding about 450 μ
g rotigotine free base equivalent per day, for treatment of a restless limb disorder. - View Dependent Claims (34, 35, 36, 37)
- and (b) indicia, on the reservoir or in or on packaging thereof, for oronasopharyngeal administration of said one or more doses in an amount not exceeding about 450 μ
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38. A pharmaceutical dosage unit comprising, in a pharmaceutically acceptable vehicle, rotigotine or a pharmaceutically acceptable salt, prodrug or metabolite thereof in an amount of about 10 to about 450 μ
- g rotigotine free base equivalent in an atomized oronasopharyngeally deliverable composition.
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39. A pharmaceutical dosage unit comprising, in a pharmaceutically acceptable vehicle, rotigotine or a pharmaceutically acceptable salt, prodrug or metabolite thereof in an amount of about 10 to about 450 μ
- g rotigotine free base equivalent, wherein the dosage unit has a pH of about 4.5 to about 6.0.
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40. A pharmaceutical dosage unit comprising, in a pharmaceutically acceptable vehicle, rotigotine or a pharmaceutically acceptable salt, prodrug or metabolite thereof in an amount of about 10 to about 450 μ
- g rotigotine free base equivalent, wherein the dosage unit is in a metered amount of about 40 to about 200 μ
l.
- g rotigotine free base equivalent, wherein the dosage unit is in a metered amount of about 40 to about 200 μ
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41. A pharmaceutical dosage unit comprising, in a pharmaceutically acceptable vehicle, rotigotine or a pharmaceutically acceptable salt, prodrug or metabolite thereof in an amount of about 10 to about 450 μ
- g rotigotine free base equivalent, wherein the dosage unit has a viscosity of about 0.5 to about 1.5 mm2/s.
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42. A pharmaceutical kit comprising (a) a composition that comprises, in a pharmaceutically acceptable vehicle, rotigotine or a pharmaceutically acceptable salt, prodrug or metabolite thereof in an amount providing one or more doses;
- and (b) a document having indicia for oronasopharyngeal administration of said one or more doses in an amount not exceeding about 450 μ
g rotigotine free base equivalent per day, in treatment of a restless limb disorder. - View Dependent Claims (44, 45, 47, 48, 50, 51, 52)
- and (b) a document having indicia for oronasopharyngeal administration of said one or more doses in an amount not exceeding about 450 μ
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43. A pharmaceutical kit comprising (a) an oral, transdermal or parenteral formulation comprising a first dopamine agonist in an amount effective for chronic treatment of a restless limb disorder;
- and (b) an oronasopharyngeal formulation comprising a second dopamine agonist in an amount effective for p.r.n. treatment to reduce occurrence and/or severity of one or more breakthrough symptoms of the disorder;
wherein the first and second dopamine agonists are the same or different.
- and (b) an oronasopharyngeal formulation comprising a second dopamine agonist in an amount effective for p.r.n. treatment to reduce occurrence and/or severity of one or more breakthrough symptoms of the disorder;
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46. A regimen for managing a restless limb disorder in a subject, comprising (a) administering a first dopamine agonist to the subject by an oral, transdermal or parenteral route in an amount effective for chronic treatment of the disorder;
- and (b) administering, transmucosally in the oronasopharyngeal chamber of the subject, a second dopamine agonist in an amount effective for p.r.n. treatment to reduce occurrence and/or severity of one or more breakthrough symptoms of the disorder;
wherein the first and second dopamine agonists are the same or different.
- and (b) administering, transmucosally in the oronasopharyngeal chamber of the subject, a second dopamine agonist in an amount effective for p.r.n. treatment to reduce occurrence and/or severity of one or more breakthrough symptoms of the disorder;
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49. A method for treating intermittent RLS in a subject, comprising administering a dopamine agonist transmucosally in the oronasopharyngeal chamber of the subject, in an amount effective to reduce occurrence and/or severity of one or more RLS symptoms.
Specification