Treatment of cataplexy

Patent metadata

Field	Value
Publication number	US-9359290-B2
Application number	US-201414205423-A
Country	US
Kind code	B2
Filing date	Mar 12, 2014
Priority date	Mar 13, 2013
Publication date	Jun 7, 2016
Grant date	Jun 7, 2016

Abstract

The present invention relates to a method of treating cataplexy in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of certain carbamate compounds.

First claim

We claim:

1. A method of treating cataplexy in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound of Formula (I):

or a pharmaceutically acceptable salt or ester thereof;
wherein R is a member selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, halogen selected from F, Cl, Br and I, alkoxy containing 1 to 3 carbon atoms, nitro, hydroxy, trifluoromethyl, and thioalkoxy containing 1 to 3 carbon atoms;
x is an integer of 0 to 3, with the proviso that R may be the same or different when x is 2 or 3;
R 1 and R 2 are independently selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, aryl, arylalkyl, cycloalkyl of 3 to 7 carbon atoms; or
R 1 and R 2 can be joined to form a 5 to 7-membered heterocycle substituted with a member selected from the group consisting of hydrogen, alkyl, and aryl groups, wherein the heterocycle can comprise 1 to 2 nitrogen atoms and 0 to 1 oxygen atom, wherein the nitrogen atoms are not directly connected with each other or with the oxygen atom.

2. The method of claim 1 , wherein x=0.

3. The method of claim 1 , wherein R 1 and R 2 are hydrogen and x=0.

4. The method of claim 1 , wherein the compound of Formula I is an enantiomer of Formula I substantially free of other enantiomers or an enantiomeric mixture wherein one enantiomer of Formula I predominates.

5. The method of claim 4 , wherein the enantiomer of Formula I predominates to the extent of about 90% or greater.

6. The method of claim 4 , wherein the enantiomer of Formula I predominates to the extent of about 98% or greater.

7. The method of claim 4 , wherein the enantiomer of Formula I is an enantiomer of Formula Ia:

or a pharmaceutically acceptable salt or ester thereof.

8. The method of claim 7 , wherein the enantiomer of Formula Ia is the (R) or (D) enantiomer.

9. The method of claim 7 , wherein the enantiomer of Formula Ia is the (S) or (L) enantiomer.

10. The method of claim 7 , wherein the enantiomer of Formula Ia predominates to the extent of about 90% or greater.

11. The method of claim 7 , wherein the enantiomer of Formula Ia predominates to the extent of about 98% or greater.

12. The method of claim 4 , wherein the enantiomer of Formula I substantially free of other enantiomers is the compound of Formula Ib or an enantiomeric mixture wherein the compound of Formula Ib predominates:

or a pharmaceutically acceptable salt or ester thereof.

13. The method of claim 12 , wherein the compound of Formula Ib predominates to the extent of about 90% or greater.

14. The method of claim 12 , wherein the compound of Formula Ib predominates to the extent of about 98% or greater.

15. The method of claim 1 , wherein the cataplexy is associated with narcolepsy.

16. The method of claim 1 , wherein the cataplexy is secondary to a condition that lowers hypocretin levels in the subject.

17. The method of claim 16 , wherein the condition is selected from the group consisting of brain tumor, astrocytomas, glioblastoma, glioma, subependynoma, craniopharyngioma, arterio-venous malformations, ischemic events, multiple sclerosis, head injury, brain surgery, paraneoplastic syndromes, Neimann-Pick type C disease, and encephalitis.

18. The method of claim 1 , wherein the therapeutically effective amount of the compound of Formula I is from about 0.01 mg/kg/dose to about 150 mg/kg/dose.

19. The method of claim 1 , wherein the therapeutically effective amount of the compound of Formula I is from about 1 mg/day to about 7000 mg/day.

20. The method of claim 1 , wherein the compound of Formula I is administered orally.

21. The method of claim 1 , wherein the compound of Formula I is administered in the form of a capsule or tablet.

22. The method of claim 1 , wherein the compound of Formula I is administered in the form of a capsule at a dose of about 150 mg to about 300 mg without any excipients.

Assignees

• Jazz Pharmaceuticals Internat Iii Ltd
• Sk Biopharmaceuticals Co Ltd

Inventors

• Khayrallah Moise A
• Bream Gary
• Butts Stephen E

Classifications

• A61P35/00

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• A61P25/20

  Hypnotics; Sedatives · CPC title

• A61P25/14

  for treating abnormal movements, e.g. chorea, dyskinesia · CPC title

• A61P25/22

  Anxiolytics · CPC title

• A61P21/00

  Drugs for disorders of the muscular or neuromuscular system · CPC title