Treating extrapyramidal syndrome using trapidil

• US 10,350,212 B2
• Filed: 04/25/2018
• Issued: 07/16/2019
• Est. Priority Date: 04/04/2016
• Status: Active Grant

• Current Assignee: Sinopia Biosciences, Inc.
• Original Assignee: Sinopia Biosciences, Inc.
• Inventors: Bordbar, Aarash
• Primary Examiner(s): Chu, Yong L
• Application Number:
  US15/962,999
• Publication Number:
  US 20180243307A1
• Time in Patent Office: 447 Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/53 having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine melarsoprol A61K31/555 ; with four nitrogen atoms A61K31/495
• CPC Class Codes: A61K 31/5377 not condensed and containing further heterocyclic rings, e.g. timolol
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61P 25/14 for treating abnormal movements, e.g. chorea, dyskinesia
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia

Abstract

Disclosed herein are methods, pharmaceutical combinations, or kits for the prevention or treatment of extrapyramidal syndromes, for example, dyskinesia, dystonia, akathisia, or drug-induced Parkinsonism, with the administration of a therapeutic effective amount of Trapidil, a derivative, a metabolite, a prodrug, an analog, or a pharmaceutically acceptable salt thereof.

Claims

1. A combination therapy method for treating or preventing a movement disorder in a subject in need thereof, comprising administering to the subject a therapeutically effective combination of:

Trapidil, a derivative, a metabolite, or a pharmaceutically acceptable salt thereof; and

levodopa;

thereby treating or preventing the movement disorder in the subject;

2. The method of claim 1, wherein the movement disorder is manifested as a dyskinesia, dystonia, akathisia, bradykinesia, tremors, or akinesia.

3. The method of claim 1, wherein the movement disorder is associated with Parkinson'"'"'s disease.

4. The method of claim 1, wherein Trapidil is N,N-diethyl-5-methyl-[1,2,4]triazolo[1,5-a]pyrimidin-7-amine.

5. The method of claim 1, wherein the pharmaceutically acceptable salt of Trapidil comprises a salt with hydrochloric acid, hydrobromic acid, hydroiodic acid, sulfuric acid, nitric acid, oxalic acid, malonic acid, or tartaric acid.

6. The method of claim 1, wherein Trapidil or a pharmaceutically acceptable salt thereof and levodopa are administered simultaneously, sequentially, or at an interval period of time.

7. The method of claim 6, wherein if sequentially, Trapidil or a pharmaceutically acceptable salt thereof is administered prior to administration of levodopa.

8. The method of claim 6, wherein if sequentially, Trapidil or a pharmaceutically acceptable salt thereof is administered after the administration of levodopa.

9. The method of claim 1, wherein Trapidil or a pharmaceutically acceptable salt thereof and levodopa are administered as a combined dosage form.

10. The method of claim 1, wherein Trapidil or a pharmaceutically acceptable salt thereof and levodopa are each independently formulated for oral administration.

11. The method of claim 1, wherein Trapidil or a pharmaceutically acceptable salt thereof and levodopa are each independently formulated for parenteral administration.

12. The method of claim 1, wherein the subject is diagnosed with Parkinson'"'"'s disease.

13. The method of claim 1, wherein the combination therapy delays onset of the movement disorder in the subject.

14. The method of claim 1, wherein Trapidil or a pharmaceutically acceptable salt thereof decreases the dose of levodopa administered to the subject relative to a dose of levodopa administered to the same subject in the absence of Trapidil or a pharmaceutically acceptable salt thereof.

15. The method of claim 1, wherein Trapidil or a pharmaceutically acceptable salt thereof potentiate the effect of levodopa.

16. The method of claim 1, wherein Trapidil or a pharmaceutically acceptable salt thereof is used as an adjuvant therapeutic agent.

17. The method of claim 1, wherein the subject is a human.

18. The method of claim 1, wherein the movement disorder is dyskinesia and the preventing is a delay in onset of dyskinesia or a slowing down of the progression of dyskinesia.

19. The method of claim 1, wherein the therapeutically effective combination does not cause levodopa-induced dyskinesia in the subject.