IP Library Granted Patent US 9,474,728
Granted Patent B2
US 9,474,728 · App. 14/477,981 · Granted Oct 25, 2016

Methods and compositions for treating fatigue associated with disordered sleep using very low dose cyclobenzaprine

Inventors: Seth Lederman (New York, NY); Herb Harris (Chapel Hill, NC)
Assignee: Tonix Pharma Holdings Limited
A61K31/135A61K9/2018A61K9/2059A61K31/137A61K45/06G06F19/70A61K9/2866
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Quick Facts
Patent No.
US 9,474,728
App. No.
14/477,981
Granted
Oct 25, 2016
Kind
B2
Abstract

The present invention relates to methods for the treatment or prevention of fatigue associated with disordered sleep, for example, in multiple sclerosis, fibromyalgia, Fabry's disease, Parkinson's disease, or traumatic brain injury, using cyclobenzaprine. The present invention further relates to a biomarker for the therapeutic effects of a cyclobenzaprine treatment.

Claims (5)

1. A method for monitoring the effectiveness of cyclobenzaprine treatment for disordered sleep in a subject at risk of suffering from disordered sleep, who has received the cyclobenzaprine treatment, the method comprising:

a) measuring the CAP A1, A2 and A3 rates in the subject;

b) generating an nCAP A2+A3 (CAP A2+A3(Norm) ) value from the measurements in a); and

c) monitoring the effectiveness of the cyclobenzaprine treatment for disordered sleep wherein the cyclobenzaprine treatment is effective when the CAP A2+A3(Norm) value generated in step b) is less than or equal to a threshold CAP A2+A3(Norm) value generated in subjects suffering from disordered sleep who have received a placebo.

2. The method of claim 1 , wherein the specified CAP A2+A3(Norm) threshold value is ≦33%.

Assignments (3)
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 039147/0520 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 13, 2016
From: TONIX PHARMACEUTICALS, INC.
To: TONIX PHARMA HOLDINGS LIMITED
Reel/Frame 039147/0595 →
Continuity (3)
Division 13157270 · Jun 9, 2011
Provisional Application 61358305 · Jun 24, 2010
Related Publication 20150065581A1 · Mar 5, 2015