IP Library Patent Application 18037815
Patent Application
App. No. 18/037,815

CYCLOBENZAPRINE TREATMENT FOR ALCOHOL USE DISORDER

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Quick Facts
Patent No.
US None
App. No.
18/037,815
Abstract

The present disclosure provides a method for treating alcohol use disorder (AUD) and associated symptoms to a subject in need thereof by administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of cyclobenzaprine or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier. The pharmaceutically acceptable salt comprises a cyclobenzaprine acid salt.

Claims (19)

1 . A method for treating alcohol use disorder (AUD) and associated symptoms, comprising administering to a subject in need thereof, a pharmaceutical composition comprising a therapeutically effective amount of cyclobenzaprine or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier.

2 . The method of claim 1 , wherein the pharmaceutical composition is administered one or more times daily.

3 . The method of claim 2 , wherein the pharmaceutical composition comprises between 0.1 mg and 30 mg of cyclobenzaprine or a pharmaceutically acceptable salt thereof.

4 . The method of claim 2 , wherein the pharmaceutical composition comprises between 1 mg and 20 mg of cyclobenzaprine or a pharmaceutically acceptable salt thereof.

5 . The method of claim 2 , wherein the pharmaceutical composition comprises less than 10 mg of cyclobenzaprine or a pharmaceutically acceptable salt thereof.

6 . The method of claim 2 , wherein the pharmaceutical composition comprises less than 5 mg of cyclobenzaprine or a pharmaceutically acceptable salt thereof.

7 . The method of claim 2 , wherein the pharmaceutical composition comprises about 5.6 mg of cyclobenzaprine or a pharmaceutically acceptable salt thereof.

8 . The method of claim 2 , wherein the pharmaceutical composition comprises about 2.8 mg of cyclobenzaprine or a pharmaceutically acceptable salt thereof.

9 . The method of claim 7 , wherein the pharmaceutical composition is administered as two dosage units, and wherein each dosage unit comprises 2.8 mg of cyclobenzaprine or a pharmaceutically acceptable salt thereof.

10 . The method of claim 7 , wherein the pharmaceutical composition is administered simultaneously as two dosage units, and wherein the combined amount in the two dosage units is 5.6 mg of cyclobenzaprine or a pharmaceutically acceptable salt thereof.

11 . The method of claim 1 , wherein the pharmaceutical composition is administered once daily.

12 . The method of claim 1 , wherein the pharmaceutical composition is administered sublingually, buccally, orally, intravenously, intramuscularly, subcutaneously, inhalationally, intranasally, transdermally, parenterally, rectally, or vaginally.

13 . The method of claim 11 , wherein the pharmaceutical composition is administered for transmucosal absorption.

14 . The method of claim 11 , wherein the pharmaceutical composition is administered sublingually.

15 . The method of claim 12 , wherein the pharmaceutically acceptable salt comprises a cyclobenzaprine acid salt and the pharmaceutical composition further comprises a basifying agent.

16 . The method of claim 15 , wherein the cyclobenzaprine acid salt is cyclobenzaprine HCl.

17 . The method of claim 1 , wherein the cyclobenzaprine or the pharmaceutically acceptable salt thereof in the pharmaceutical composition comprises at least in part a eutectic of cyclobenzaprine or a pharmaceutically acceptable salt thereof and mannitol.

18 . The method of claim 1 , wherein the pharmaceutical composition is administered in combination with behavioral or environmental intervention.

19 . The method of claim 1 , wherein the pharmaceutical composition is administered before, during, or after detoxification.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 21, 2024
From: TONIX PHARMACEUTICALS HOLDING CORP.
To: TONIX PHARMA LIMITED
Reel/Frame 069356/0314 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 19, 2023
From: LEDERMAN, SETH; SULLIVAN, GREGORY M.
To: TONIX PHARMACEUTICALS HOLDING CORP.
Reel/Frame 063700/0061 →