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Methods of treating acute stress disorder and posttraumatic stress disorder

A post-traumatic stress and trauma technology, applied in the direction of pharmaceutical formulations, organic active ingredients, medical preparations containing active ingredients, etc., can solve the problems of ASD or PTSD that are difficult to achieve and drugs are ineffective

Pending Publication Date: 2021-07-30
TONIX PHARMA HLDG LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Treating ASD or PTSD is already hard to come by in the field of drug therapy
In pursuit of pharmacological treatment, studies evaluating the efficacy of tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), and serotonin reuptake inhibitors (SSRIs) have been conducted, but these drugs are often ineffective
For example, in ASD or very early PTSD, a study examining the efficacy of the SSRI escitalopram (commonly used to treat depression) showed that the treatment performed no better than placebo in preventing the development of PTSD (Shalev et al. People, 2012)

Method used

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  • Methods of treating acute stress disorder and posttraumatic stress disorder
  • Methods of treating acute stress disorder and posttraumatic stress disorder
  • Methods of treating acute stress disorder and posttraumatic stress disorder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0339] Example 1. Cyclobenzaprine Sublingual Formulation TNX-102SL

[0340] TNX-102SL is a sublingual formulation containing a eutectic melt of cyclobenzaprine hydrochloride (active ingredient) and D-mannitol. The formulation also contains a dibasic potassium salt. Table 1 shows the specific composition of TNX-102SL tablets.

[0341] Table 1: TNX-102SL Sublingual Tablet Composition

[0342]

[0343] a Mannitol: about 0.7 mg of the 2.5 mg total amount is a eutectic component, and the remainder is diluent.

[0344] b Flash is the trade name for an excipient containing approximately 80% mannitol and 20% cornstarch.

[0345] c Calculated as HCl salt

Embodiment 2

[0346] Example 2. Efficacy of TNX-102SL for the treatment of PTSD

[0347] Two 12-week multicenter, randomized, double-blind, placebo-controlled, fixed-dose trials (P201 and P301) were conducted to investigate the efficacy and safety of a sublingual formulation of cyclobenzaprine (TNX-102SL). Both trials required PTSD DSM-5 Criterion A trauma occurring during military service since 2001; no antidepressants for ≥ 2 months; no or washed off other psychotropic medications. Both ruled out serious risk of suicide (intention or planning; attempt within one year); substance use disorder (SUD) within 6 months; lifetime of bipolar disorder, psychotic disorder, OCD, or antisocial personality disorder.

[0348] The trial analyzed the change from baseline in the severity of PTSD symptoms over the course of 12 weeks of treatment by subjects treated with a sublingual cyclobenzaprine formulation (TNX-102SL, 5.6 mg) and those receiving placebo. Between-subjects as measured by the DSM-5 Clini...

Embodiment 3

[0363] Cyclobenzaprine metabolism in subjects with a history of smoking

[0364] Determining a therapeutic dose of cyclobenzaprine, amitriptyline, or a pharmaceutically acceptable salt thereof is important to the overall efficacy of the treatment. Therapeutic dosage may be affected by various factors, including the subject's history of smoking and other drug use. In one aspect of the disclosure, subjects with a history of smoking have an attenuated response to treatment with TNX-102SL. Such as Figure 5 Depicted, after 4 weeks of treatment, subjects with a history of smoking (bottom) had a reduction in CAPS-5 scores relative to subjects receiving placebo. However, this was to a lesser extent than for subjects with no history of smoking (top). Furthermore, after 8 and 12 weeks of treatment, respectively, the subjects' response to the treatment eventually leveled off relative to the placebo. Smoking is known to be a strong inducer of CYP1A2. Without wishing to be bound by t...

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Abstract

This invention relates to methods of treating posttraumatic stress disorder and acute stress disorder using pharmaceutical compositions comprising cyclobenzaprine, amitriptyline, or pharmaceutically acceptable salts thereof. In particular, it relates to methods of treating posttraumatic stress disorder or one or more symptoms thereof in a subject who has experienced a traumatic event less than or equal to about 9 years prior to the commencement or treatment. It also relates to methods of treating acute stress disorder or one or more symptoms thereof in a subject who has experienced a traumatic event less than or equal to about 1 month prior to the commencement of treatment.

Description

technical field [0001] This application claims priority to and benefit of U.S. Provisional Patent Application 62 / 720,063, filed August 20, 2018, the contents and disclosure of which are incorporated herein by reference in their entirety. [0002] The present application relates to methods for treating acute stress disorder, post-traumatic stress disorder and related symptoms thereof. Of particular interest are methods comprising administering to a subject a pharmaceutical composition comprising cyclobenzaprine, amitriptyline, or a pharmaceutically acceptable salt thereof, the subject initially Have experienced PTSD or ASD-induced traumatic events less than or equal to about 9 years prior to commencement of treatment. Background technique [0003] The development of posttraumatic stress disorder (PTSD) is triggered by exposure to traumatic events and leads to symptoms including: difficulty sleeping, nightmares, irritability, difficulty concentrating, hypervigilance, and pers...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/138A61P25/24A61K31/55
CPCA61P25/24A61K45/06A61K31/135A61K9/00A61K2300/00A61P25/00A61K31/137
Inventor P·S·彼特斯G·M·苏利文E·玛丽奥H·哈里斯S·雷德曼
Owner TONIX PHARMA HLDG LTD
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