IP Library Granted Patent US 9,918,948
Granted Patent B2
US 9,918,948 · App. 12/948,828 · Granted Mar 20, 2018

Methods and compositions for treating symptoms associated with post-traumatic stress disorder using cyclobenzaprine

Inventors: Seth Lederman (New York, NY); Herbert Harris (Chapel Hill, NC)
Assignee: TONIX PHARMA HOLDINGS LIMITED
A61K31/135A61K31/01A61K31/015A61K31/13A61K31/131
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Quick Facts
Patent No.
US 9,918,948
App. No.
12/948,828
Granted
Mar 20, 2018
Kind
B2
Abstract

The present invention relates to methods for the treatment or prevention of symptoms associated with post-traumatic stress disorder, and related pharmaceutical compositions. Of particular interest are pharmaceutical compositions comprising a very low dose of cyclobenzaprine, alone, or in combination with an alpha-1-adrenergic receptor antagonist, a beta-adrenergic antagonist, an anticonvulsant, a selective serotonin reuptake inhibitor or a serotonin-norepinephrine reuptake inhibitor.

Claims (11)

1. A method for treating post-traumatic stress disorder (PTSD) following a traumatic event, comprising: administering to a human in need of such treatment a pharmaceutical composition comprising cyclobenzaprine in a therapeutically effective amount and a therapeutically effective carrier, wherein such treatment eliminates or ameliorates the PTSD.

2. The method of claim 1 , wherein the amount of cyclobenzaprine administered is between 0.1 mg and 50 mg/day.

3. The method of claim 2 , wherein the amount of cyclobenzaprine administered is between 0.5 mg and 30 mg/day.

4. The method of claim 3 , where the amount of cyclobenzaprine administered is between 1 mg and 20 mg/day.

5. The method of claim 1 , wherein the amount of cyclobenzaprine administered is less than 5 mg/day.

6. The method of claim 5 , wherein the amount of cyclobenzaprine administered is less than 2.5 mg/day.

7. The method of claim 1 , wherein the method further comprises administering sequentially or concurrently a drug selected from the group consisting of an alpha-1-adrenergic receptor antagonist, a beta-adrenergic antagonist, an anticonvulsant, a selective serotonin reuptake inhibitor and a serotonin-norepinephrine reuptake inhibitor.

8. The method of claim 7 , wherein the alpha-1-adrenergic receptor antagonist is prazosin.

9. The method of claim 8 , wherein the selective serotonin reuptake inhibitor is sertraline, paroxetine, fluoxetine, citalopram or escitalopram.

10. The method of claim 1 , wherein the pharmaceutical composition is administered as an orally dissolving tablet or as a thin film formulation.

11. The method of claim 1 , wherein the pharmaceutical composition is administered in combination with psychotherapeutic intervention.

Assignments (5)
NOVATION AGREEMENT Recorded Sep 25, 2024
From: TONIX PHARMA HOLDINGS LIMITED
To: TONIX PHARMA LIMITED
Reel/Frame 069504/0760 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 13, 2016
From: LEDERMAN, SETH; HARRIS, HERB
To: TONIX PHARMACEUTICALS, INC.
Reel/Frame 039325/0812 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 13, 2016
From: TONIX PHARMACEUTICALS, INC.
To: TONIX PHARMA HOLDINGS LIMITED
Reel/Frame 039325/0820 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE NAME, PREVIOUSLY RECORDED AT REEL: 025620 FRAME: 0592. ASSIGNOR(S) HEREBY CONFIRMS THE ASSOGNMENT. Recorded Dec 29, 2015
From: LEDERMAN, SETH; HARRIS, HERB
To: TONIX PHARMACEUTICALS, INC.
Reel/Frame 037396/0393 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 17, 2010
From: LEDERMAN, SETH; HARRIS, HERB
To: TONIX PHARMACEUTICALS
Reel/Frame 025620/0592 →
Continuity (2)
Provisional Application 61281661 · Nov 20, 2009
Related Publication 20110124656A1 · May 26, 2011