IP Library › Granted Patent US 11,452,692
Granted Patent B2
US 11,452,692 · App. 17/649,826 · Granted Sep 27, 2022

Compositions and methods for treating disorders ameliorated by muscarinic receptor activation

Inventors: Aimesther Betancourt (Montreal, CA); Bruce Rehlaender (Lake Oswego, OR); Roch Thibert (Mont-Royal, CA)
Assignee: Karuna Therapeutics, Inc.
A61K9/1652A61K9/0053A61K9/1611A61K9/485A61K9/4858A61K9/4866A61K31/439A61K31/454
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Quick Facts
Patent No.
US 11,452,692
App. No.
17/649,826
Granted
Sep 27, 2022
Kind
B2
Abstract

Provided herein is an oral pharmaceutical composition, comprising a plurality of xanomeline beads having a core comprising xanomeline or a salt thereof; and a plurality of trospium beads having a core comprising a salt of trospium.

Claims (21)

1. A method of treating a disorder ameliorated by activating muscarinic receptors in a patient in need thereof, the method comprising administering between 100 mg and 125 mg xanomeline and/or a salt thereof and between 20 mg and 30 mg trospium salt to the patient twice daily;

wherein the xanomeline and/or a salt thereof and trospium salt are administered as a pharmaceutical composition comprising a plurality of xanomeline beads having a core comprising the xanomeline or a salt thereof and optionally a coating, and a plurality of trospium beads having a core comprising the trospium salt and optionally a coating; and

wherein the pharmaceutical composition is a capsule containing the plurality of xanomeline beads and the plurality of trospium beads.

2. The method of claim 1 , wherein the disorder is chosen from schizophrenia, Alzheimer's disease, Parkinson's disease, depression, movement disorders, pain, drug addiction, tauopathy, and synucleinopathy.

3. The method of claim 1 , wherein the disorder is schizophrenia.

4. The method of claim 1 , wherein the administration is oral.

5. The method of claim 1 , wherein the patient is treated for at least 7 days.

6. The method of claim 1 , wherein the xanomeline and/or a salt thereof is xanomeline tartrate.

7. The method of claim 1 , wherein the trospium salt is trospium chloride.

8. The method of claim 1 , wherein the xanomeline and/or a salt thereof is xanomeline tartrate and the trospium salt is trospium chloride.

9. A method of treating schizophrenia in a patient in need thereof, the method comprising orally administering between 100 mg and 125 mg xanomeline tartrate and between 20 mg and 30 mg trospium chloride to the patient twice daily;

wherein the xanomeline and/or a salt thereof and trospium salt are administered as a pharmaceutical composition comprising a plurality of xanomeline beads having a core comprising the xanomeline or a salt thereof and optionally a coating, and a plurality of trospium beads having a core comprising the trospium salt and optionally a coating.

10. The method of claim 9 , wherein the patient is treated for at least 7 days.

11. The method of claim 1 , wherein the size of the xanomeline beads is between 0.425 mm and 1.18 mm.

12. The method of claim 11 , wherein the size of the xanomeline beads is between 0.6 mm and 0.85 mm.

13. The method of claim 1 , wherein the size of the trospium beads is between 0.425 mm and 1.18 mm.

14. The method of claim 13 , wherein the size of the trospium beads is between 0.6 mm and 0.85 mm.

15. The method of claim 9 , wherein the size of the xanomeline beads is between 0.425 mm and 1.18 mm.

16. The method of claim 15 , wherein the size of the xanomeline beads is between 0.6 mm and 0.85 mm.

17. The method of claim 9 , wherein the size of the trospium beads is between 0.425 mm and 1.18 mm.

18. The method of claim 17 , wherein the size of the trospium beads is between 0.6 mm and 0.85 mm.

Assignments (6)
CERTIFICATE OF CHANGE OF ASSIGNEE PRINCIPAL BUSINESS ADDRESS Recorded Oct 22, 2024
From: KARUNA THERAPEUTICS, INC.
To: KARUNA THERAPEUTICS, INC.
Reel/Frame 069205/0476 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 25, 2022
From: BETANCOURT, AIMESTHER
To: COREALIS PHARMA
Reel/Frame 059105/0009 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 25, 2022
From: THIBERT, ROCH
To: COREALIS PHARMA
Reel/Frame 059105/0093 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 25, 2022
From: COREALIS PHARMA
To: KARUNA THERAPEUTICS, INC.
Reel/Frame 059105/0201 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 25, 2022
From: REHLAENDER, BRUCE
To: PHARMADIRECTIONS, INC.
Reel/Frame 059105/0254 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 25, 2022
From: PHARMADIRECTIONS, INC.
To: KARUNA THERAPEUTICS, INC.
Reel/Frame 059105/0386 →
Continuity (4)
Continuation 17143904 · Jan 7, 2021
Continuation 16585532 · Sep 27, 2019
Provisional Application 62738333 · Sep 28, 2018
Related Publication 20220151933A1 · May 19, 2022
Cited By (1)
US 12,558,317