IP Library Granted Patent US 11,072,579
Granted Patent B2
US 11,072,579 · App. 16/359,446 · Granted Jul 27, 2021

Treatment of cataplexy

Inventors: Moise A. Khayrallah (Morrisville, NC); Gary Bream (Cary, NC); Stephen E. Butts (Holly Springs, NC)
Assignees: Jazz Pharmaceuticals Ireland Limited; SK Biopharmaceuticals Co., Ltd.
C07C271/02A61K9/0053A61K9/20A61K31/27A61K31/325A61K45/06C07C271/00
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Quick Facts
Patent No.
US 11,072,579
App. No.
16/359,446
Granted
Jul 27, 2021
Kind
B2
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.

Claims (17)

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 4 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 4 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 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.

4. The method of claim 3 , wherein the enantiomer of Formula I predominates to the extent of about 98% or greater.

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

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

7. The method of claim 6 , 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.

8. 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.

9. 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.

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

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

12. 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.

Assignments (6)
SECURITY INTEREST Recorded May 9, 2025
From: AXSOME THERAPEUTICS, INC.; AXSOME MALTA LTD.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 071247/0836 →
RELEASE OF SECURITY INTEREST Recorded May 6, 2025
From: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION, AS SUCCESSOR IN INTEREST TO U.S. BANK NATIONAL ASSOCIATION
To: JAZZ PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 071034/0467 →
SECURITY INTEREST Recorded Sep 9, 2024
From: AXSOME MALTA LTD
To: HERCULES CAPITAL, INC.
Reel/Frame 068900/0023 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 16, 2022
From: JAZZ PHARMACEUTICALS IRELAND LIMITED
To: AXSOME MALTA LTD.
Reel/Frame 060223/0878 →
SECURITY AGREEMENT Recorded May 5, 2021
From: CAVION, INC.; CELATOR PHARMACEUTICALS, INC.; JAZZ PHARMACEUTICALS IRELAND LIMITED; JAZZ PHARMACEUTICALS, INC.
To: U.S. BANK NATIONAL ASSOCIATION
Reel/Frame 056151/0010 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 3, 2019
From: JAZZ PHARMACEUTICALS INTERNATIONAL III LIMITED
To: JAZZ PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 049666/0456 →