Methods of treating Parkinson's disease

Patent metadata

Field	Value
Publication number	US-11091507-B2
Application number	US-202016866400-A
Country	US
Kind code	B2
Filing date	May 4, 2020
Priority date	Oct 21, 2014
Publication date	Aug 17, 2021
Grant date	Aug 17, 2021

Abstract

The present disclosure relates to (a) carbidopa prodrugs, (b) pharmaceutical combinations and compositions comprising a carbidopa prodrug and/or an L-dopa prodrug, and (c) methods of treating Parkinson's disease and associated conditions comprising administering a carbidopa prodrug and an L-dopa prodrug to a subject with Parkinson's disease.

First claim

What is claimed is:

1. A method of delivering dopamine to a Parkinson's disease patient in a pharmacokinetically-consistent manner comprising, continuously subcutaneously administering an aqueous pharmaceutical formulation to the patient, the formulation comprising:
(a) at least about 5 mg/mL of a compound comprising levodopa,
(b) carbidopa, or a pharmaceutically acceptable salt thereof, and
(c) an aqueous carrier,

wherein the method is sufficient to achieve a steady state levodopa plasma level of about 1000 ng/ml to about 5000 ng/ml in the patient for at least 8 hours without co-administration of a catechol-0-methyl transferase inhibitor.

2. The method of claim 1 , wherein the method is sufficient to achieve a steady state levodopa plasma level in the patient for at least 16 hours.

3. The method of claim 1 , wherein the method is sufficient to achieve a steady state levodopa plasma level in the patient for at least 24 hours.

4. The method of claim 1 , wherein the steady state levodopa plasma level in the patient is achieved without an oral medication for Parkinson's Disease.

5. The method of claim 1 , wherein the method is sufficient to achieve a steady state levodopa plasma level in the patient of about 1000 ng/ml +/− about 10%.

6. The method of claim 1 , wherein the method is sufficient to achieve a steady state levodopa plasma level in the patient of about 2000 ng/ml +/− about 10%.

7. The method of claim 1 , wherein the method is sufficient to achieve a steady state levodopa plasma level in the patient of about 3000 ng/ml +/− about 10%.

8. The method of claim 1 , wherein the method is sufficient to achieve a steady state levodopa plasma level in the patient from about 1500 ng/ml to about 5000 ng/ml.

9. The method of claim 8 , wherein the method is sufficient to achieve a steady state levodopa plasma level in the patient for at least 16 hours.

10. The method of claim 8 , wherein the method is sufficient to achieve a steady state levodopa plasma level in the patient for at least 24 hours.

11. The method of claim 1 , wherein the method is sufficient to achieve a steady state levodopa plasma level in the patient from about 2000 ng/ml to about 4000 ng/ml.

12. The method of claim 11 , wherein the method is sufficient to achieve a steady state levodopa plasma level in the patient for at least 16 hours.

13. The method of claim 11 , wherein the method is sufficient to achieve a steady state levodopa plasma level in the patient for at least 24 hours.

14. The method of claim 1 , wherein the formulation comprises at least about 10 mg/mL of the compound comprising levodopa.

15. The method of claim 1 , wherein the formulation comprises at least about 20 mg/mL of the compound comprising levodopa.

16. The method of claim 1 , wherein the formulation comprises at least about 30 mg/mL of the compound comprising levodopa.

17. The method of claim 1 , wherein the formulation comprises at least about 50 mg/mL of the compound comprising levodopa.

Assignees

• Abbvie Inc

Inventors

• Enright Brian P
• Huang Ye
• Kym Philip R
• Lao Yanbin
• Lou Xiaochun
• Mackey Sean E
• Mayer Peter T
• Miller Christopher P
• Stella Valentino J
• Voight Eric A

Classifications

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• C07F9/094 Primary

  with arylalkanols · CPC title

• C07C309/24

  of a carbon skeleton containing six-membered aromatic rings · CPC title

• C07C281/02

  Compounds containing any of the groups [IMAGE cpc-sch-C07C-0972.gif], e.g. carbazates · CPC title

• C07C47/277

  containing ether groups, [IMAGE cpc-sch-C07C-0958.gif] groups,[IMAGE cpc-sch-C07C-0959.gif] groups, or[IMAGE cpc-sch-C07C-0960.gif] groups · CPC title