Last update 01 Jul 2024

Cyclobenzaprine hydrochloride

Last update 01 Jul 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryCyclobenzaprine is a small molecule drug that antagonizes ADRA2, 5-HT2A receptor, and H1 receptor, and has been approved for the treatment of muscle spasticity, fibromyalgia, stress disorders, low back pain, COVID-19, and post-COVID syndrome. Its mechanism of action reduces the excitability of motor neurons and skeletal muscles, while diminishing anxiety, pain, and inflammation. Johnson & Johnson developed the drug, first approved in 1977, but it can cause side effects like drowsiness, dry mouth, and dizziness, which requires careful monitoring by healthcare providers. Cyclobenzaprine can provide therapeutic benefits for a wide range of clinical indications, but its administration requires prudence, particularly for patients with underlying medical conditions, such as hepatic or renal impairment. Hence, healthcare providers must be well-informed regarding the patient's medical history before administering this medication.

Drug Type

Small molecule drug

Synonyms

(3-Dibenzo[a,d]cyclohepten-5-ylidene-propyl)-dimethyl-amine, Cyclobenzaprine, Cyclobenzaprine hydrochloride (USP)

+ [12]

Target

5-HT2A receptor x ADRA2 x H1 receptor

Mechanism

5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), ADRA2 antagonists(Adrenergic receptors alpha-2 antagonists), H1 receptor antagonists(Histamine H1 receptor antagonists)

Therapeutic Areas

Nervous System DiseasesSkin and Musculoskeletal DiseasesInfectious Diseases+ [2]

Active Indication

Muscle SpasticityAcute low back painFibromyalgia+ [3]

Inactive Indication

Migraine DisordersMyofascial Pain SyndromesStress Disorders, Post-Traumatic

Originator Organization

Johnson & Johnson

Active Organization

Tonix Pharmaceuticals, Inc.Teva Pharmaceuticals International GmbH

Inactive Organization

Shandong Bestcomm Pharmaceutical Co., Ltd.Teva Pharmaceuticals USA, Inc.Janssen Research & Development LLC

Drug Highest PhaseApproved

First Approval Date

US (26 Aug 1977),

Muscle Spasticity

Regulation-

Structure

Molecular FormulaC20H22ClN

InChIKeyVXEAYBOGHINOKW-UHFFFAOYSA-N

CAS Registry6202-23-9

Clinical Trials associated with Cyclobenzaprine hydrochloride

CTR20231737 / CompletedNot Applicable

在空腹和餐后条件下，采用单中心、随机、开放、单剂量、两制剂、两周期、两交叉设计，评价盐酸环苯扎林缓释胶囊受试制剂与参比制剂在健康成年受试者中的生物等效性

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-crossover design was used to evaluate the bioequivalence of the test formulation and the reference formulation of cyclobenzaprine hydrochloride extended-release capsules in healthy adult subjects under fasting and fed conditions.

主要研究目的：考察在空腹/餐后条件下，在中国健康受试者中评价鲁南贝特制药有限公司研制的盐酸环苯扎林缓释胶囊（规格：30mg）与Teva Pharmaceuticals International GmbH持有的盐酸环苯扎林缓释胶囊（商品名：Amrix；规格：30mg）的人体生物等效性。次要研究目的观察在空腹/餐后条件下，盐酸环苯扎林缓释胶囊受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Main study objectives: To evaluate the bioequivalence of cyclobenzaprine hydrochloride sustained-release capsules (specification: 30 mg) developed by Runan Beite Pharmaceutical Co., Ltd. and cyclobenzaprine hydrochloride sustained-release capsules (trade name: Amrix; specification: 30 mg) held by Teva Pharmaceuticals International GmbH in healthy Chinese subjects under fasting/fed conditions. Secondary study objectives To observe the safety of the test and reference preparations of cyclobenzaprine hydrochloride sustained-release capsules in healthy Chinese subjects under fasting/fed conditions.

Start Date24 Jun 2023

Sponsor / Collaborator

LUNAN BETTER PHARMACEUTICAL CO.,LTD.

RBR-9yy8w2k / RecruitingNot Applicable

Effect of Neuroscience-based Pain Education associated with Cyclobenzaprine administration in patients with Masticatory Myofascial Pain: a double blind randomized controlled clinical trial

Start Date14 Nov 2022

Sponsor / Collaborator

Universidade Federal de Minas Gerais

[+1]

NCT05372887 / WithdrawnPhase 2

A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Daily Bedtime TNX-102 SL in Participants With PTSD

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.

Start Date14 Oct 2022

Sponsor / Collaborator

Tonix Pharmaceuticals, Inc.

100 Clinical Results associated with Cyclobenzaprine hydrochloride

100 Translational Medicine associated with Cyclobenzaprine hydrochloride

100 Patents (Medical) associated with Cyclobenzaprine hydrochloride

305

Literatures (Medical) associated with Cyclobenzaprine hydrochloride

01 Jan 2024·Journal of the American Geriatrics Society

Baclofen and the risk of fall and fracture in older adults: A real‐world cohort study

Article

Author: Hwang, Y Joseph ; Inker, Lesley A ; Brotman, Daniel J ; Grams, Morgan E ; Shin, Jung-Im ; Chang, Alex R

Abstract:

Background:

The growth of oral muscle relaxant prescriptions among older adults in the United States is concerning due to the drugs' adverse sedative effects. Baclofen is a gamma‐aminobutyric acid agonist muscle relaxant that is associated with encephalopathy. We characterized the risk of fall and fracture associated with oral baclofen against other muscle relaxants (tizanidine or cyclobenzaprine) in older adults.

Methods:

We designed a new‐user, active‐comparator study using tertiary health system data from Geisinger Health, Pennsylvania (January 2005 through December 2018). Older adults (aged ≥65 years) newly treated with baclofen, tizanidine, or cyclobenzaprine were included. Propensity score‐based inverse probability of treatment weighting (IPTW) was used to balance the treatment groups on 58 baseline characteristics. Fine–Gray competing risk regression was used to estimate the risk of fall and fracture.

Results:

The study cohort comprised of 2205 new baclofen users, 1103 new tizanidine users, and 9708 new cyclobenzaprine users. During a median follow‐up of 100 days, baclofen was associated with a higher risk of fall compared to tizanidine (IPTW incidence rate, 108.4 vs. 61.9 per 1000 person‐years; subdistribution hazard ratio [SHR], 1.68 [95% CI, 1.20–2.36]). The risk of fall associated with baclofen was comparable to cyclobenzaprine (SHR, 1.17 [95% CI, 0.93–1.47]) with a median follow‐up of 106 days. The risk of fracture was similar among patients treated with baclofen versus tizanidine (SHR, 0.85 [95% CI, 0.63–1.14]) or cyclobenzaprine (SHR, 0.85 [95% CI, 0.67–1.07]).

Conclusions:

The risk of fall associated with baclofen was greater than tizanidine, but not compared to cyclobenzaprine in older adults. The risk of fracture was comparable among the older users of baclofen, tizanidine, and cyclobenzaprine. Our findings may inform risk‐benefit considerations in the increasingly common clinical encounters where oral muscle relaxants are prescribed.

15 Dec 2023·Spine

Postoperative Use of the Muscle Relaxants Baclofen and/or Cyclobenzaprine Associated With an Increased Risk of Delirium Following Lumbar Fusion

Article

Author: Banks, Matthew ; Piscopo, Anthony ; Mueller, Rashmi N ; Perez, Eli A ; Gold, Colin J ; Olinger, Catherine R ; Sanders, Robert D ; Ray, Emanuel ; Park, Brian J ; Carnahan, Ryan M ; Woodroffe, Royce W

Study Design.:

Retrospective, single-center, cohort study.

Objective.:

Investigate whether the incidence of postoperative delirium in older adults undergoing spinal fusion surgery is associated with postoperative muscle relaxant administration.

Summary of Background Data.:

Baclofen and cyclobenzaprine are muscle relaxants frequently used for pain management following spine surgery. Muscle relaxants are known to cause central nervous system side effects in the outpatient setting and are relatively contraindicated in individuals at high risk for delirium. However, there are no known studies investigating their side effects in the postoperative setting.

Methods.:

Patients over 65 years of age who underwent elective posterior lumbar fusion for degenerative spine disease were stratified into two treatment groups based on whether postoperative muscle relaxants were administered on postoperative day one as part of a multimodal analgesia regimen. Doubly robust inverse probability weighting with cox regression for time-dependent covariates was used to examine the association between postoperative muscle relaxant use and the risk of delirium while controlling for variation in baseline characteristics.

Results.:

The incidence of delirium was 17.6% in the 250 patients who received postoperative muscle relaxants compared with 7.9% in the 280 patients who did not receive muscle relaxants (P=0.001). Multivariate analysis to control for variation in baseline characteristics between treatment groups found that patients who received muscle relaxants had a 2.00 (95% CI: 1.14–3.49) times higher risk of delirium compared with controls (P=0.015).

Conclusion.:

Postoperative use of muscle relaxants as part of a multimodal analgesia regimen was associated with an increased risk of delirium in older adults after lumber fusion surgery. Although muscle relaxants may be beneficial in select patients, they should be used with caution in individuals at high risk for postoperative delirium.

01 Dec 2023·Journal of pharmaceutical sciences

Development of Extended-Release Formulations Containing Cyclobenzaprine Based on Physiologically Based Biopharmaceutics Modeling and Bioequivalence Safe Space

Article

Author: Issa, Michele Georges ; Miranda Dos Santos, Everton ; Duque, Marcelo Dutra ; Ferraz, Humberto Gomes

The use of physiologically based biopharmaceutics modeling (PBBM) and bioequivalence safe space is increasingly common for immediate-release drug products. However, for extended-release (ER) formulations there are only a few examples of this application. In this study, we developed ER formulations containing cyclobenzaprine 15 mg, supported by PBBM and bioequivalence safe space. Four formulations were prepared, F1, F2, F3 (ER mini-tablet formulations) and F4 (ER tablet formulation), and the dissolution profiles were evaluated. The dissolution profile of the reference drug product was also evaluated and used to set a bioequivalence safe space. A PBBM was set up, evaluated, and used to predict the in vivo behavior of the formulations. The bioequivalence safe space was calculated to be between - 25% and + 75% of the k1 and Tlag values of the dissolution profile of the reference drug product when applying the first-order dissolution kinetic model. All time points of the dissolution profile of the ER mini-tablet formulation F2, were within the safe space, and was approved in 10 of 10 trials of crossover virtual bioequivalence studies. Based on the PBBM strategy and bioequivalence safe space, it was possible to develop an ER mini-tablet formulation virtually bioequivalent to the reference drug product, even though this formulation failed the f2 test.

222

News (Medical) associated with Cyclobenzaprine hydrochloride

01 Jul 2024

·www.globenewswire.com

Tonix Pharmaceuticals Awarded Up to $34 Million U.S. Department of Defense Contract for Accelerated Development of Broad-Spectrum Antiviral Program

Defense Threat Reduction Agency (DTRA) contract is expected to advance development of Tonix’s broad-spectrum oral antiviral program TNX-4200 for medical countermeasuresCHATHAM, N.J., July 01, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced it has been awarded an Other Transaction Agreement (OTA) with a potential for up to $34 million over five years by the Defense Threat Reduction Agency (DTRA), an agency within the U.S. Department of Defense (DoD). The objective of the contract is to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix’s program will focus on optimization and development of its TNX-4200 program, to develop an orally available CD45 antagonist, with broad-spectrum efficacy against a range of viral families through preclinical evaluation. The program is expected to establish physicochemical properties, pharmacokinetics, and safety attributes to support an Investigational New Drug (IND) submission and to fund a first-in-human Phase 1 clinical study. “Through our agreement with DTRA, our broad-spectrum antiviral research program will address the DoD’s goal of protecting U.S. Joint Forces in the event biological weapons are introduced onto the battlefield,” said Seth Lederman, M.D., President, and Chief Executive Officer of Tonix. “The DoD announced in December 2022 that they are moving beyond a ‘one bug, one drug’ approach and are seeking broad-spectrum drugs since one cannot predict which or how many viruses may be deployed.1 This funding provides important validation for our ongoing research and current in-house capabilities, and will enable Tonix to advance its antiviral discovery program.” The $34 million five-year contract will help fund and accelerate the development of the Company’s broad-spectrum antiviral program, which has the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Tonix plans to leverage previous research on phosphatase inhibitors, specifically compounds that target CD45, to optimize lead compounds for therapeutic intervention of biothreat agents and provide the government with a complete and cost-effective solution for a broad-spectrum medical countermeasure. Tonix’s premise is that partial inhibition of CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations, a lower dose, and a better safety profile. Tonix will utilize its state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at its research and development center (RDC) located in Frederick, Md., as well as experienced personnel in-house. The RDC is located in Maryland’s ‘I-270 biotech corridor’ and is close to the center of the U.S. biodefense research community. 1 “Approach for Research, Development, and Acquisition of Medical Countermeasure and Test Products.” 2022. Chemical and Biological Defense Program. U.S. Department of Defense. https://media.defense.gov/2023/Jan/10/2003142624/-1/-1/0/APPROACH-RDA-MCM-TEST-PRODUCTS.PDF (accessed March 5, 2024) About Defense Threat Reduction Agency (DTRA) The Defense Threat Reduction Agency (DTRA), an agency within the United States Department of Defense (DoD) is both a Defense Agency and Combat Support Agency with two distinct yet highly integrated roles countering Weapons of Mass Destruction (WMD) and emerging threats. Its origins stretch back to World War II and the Manhattan Project, but today the agency encompasses a wide variety of strategic and operational functions that deter, prevent, and ultimately prevail against these unique threats. DTRA enables the Department of Defense (DoD), the United States Government and international partners to counter and deter weapons of mass destruction (WMD) and emerging threats. DTRA provides cross-cutting solutions to enable the Department of Defense, the United States Government, and international partners to deter strategic attack against the United States and its allies; prevent, reduce, and counter WMD and emerging threats; and prevail against WMD-armed adversaries in crisis and conflict. DTRA’s continued effort to enhance the combat support mission also advances public health services by developing innovative technologies that protect against biological threats. For more information, visit www.dtra.mil. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. *Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. 1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at www.tonixpharma.com. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor Contact Jessica MorrisTonix Pharmaceuticalsinvestor.relations@tonixpharma.com (862) 904-8182 Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443) 213-0505 Media Contact Katie DodgeLaVoieHealthSciencekdodge@lavoiehealthscience.com (978) 360-3151

Phase 3Immunotherapy

28 Jun 2024

·www.globenewswire.com

Tonix Pharmaceuticals Announces Closing of $4.0 Million Public Offering

CHATHAM, N.J., June 28, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 2,833,900 shares of its common stock and pre-funded warrants to purchase up to 4,228,158 shares of common stock in a public offering at an offering price of $0.57 per share of common stock and $0.569 per pre-funded warrant. The warrants have an exercise price of $0.001 per share and became exercisable upon issuance. The gross proceeds of the offering are $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness. Dawson James Securities, Inc. acted as the sole placement agent for the offering. Lowenstein Sandler, New York, NY, represented the Company in connection with the offering, and ArentFox Schiff LLP, Washington, DC, represented the placement agent. This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering was made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering were filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Tonix Pharmaceuticals Holding Corp.*Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. 1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at www.tonixpharma.com. Forward Looking StatementsCertain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the intended use of proceeds from the public offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor ContactJessica MorrisTonix Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182 Peter VozzoICR Westwickepeter.vozzo@westwicke.com(443) 213-0505 Media ContactKatie DodgeLaVoieHealthSciencekdodge@lavoiehealthscience.com(978) 360-3151

Phase 3

28 Jun 2024

·www.biospace.com

Tonix Pharmaceuticals Announces Closing of $4.0 Million Public Offering - June 28, 2024

CHATHAM, N.J., June 28, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 2,833,900 shares of its common stock and pre-funded warrants to purchase up to 4,228,158 shares of common stock in a public offering at an offering price of $0.57 per share of common stock and $0.569 per pre-funded warrant. The warrants have an exercise price of $0.001 per share and became exercisable upon issuance. The gross proceeds of the offering are $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness. Dawson James Securities, Inc. acted as the sole placement agent for the offering. Lowenstein Sandler, New York, NY, represented the Company in connection with the offering, and ArentFox Schiff LLP, Washington, DC, represented the placement agent. This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering was made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering were filed with the SEC and are available on the SEC’s website located at Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. *Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. 1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the intended use of proceeds from the public offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor Contact Jessica Morris Tonix Pharmaceuticals investor.relations@tonixpharma.com (862) 904-8182 Peter Vozzo ICR Westwicke peter.vozzo@westwicke.com (443) 213-0505 Media Contact Katie Dodge LaVoieHealthScience kdodge@lavoiehealthscience.com (978) 360-3151

Phase 3

100 Deals associated with Cyclobenzaprine hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00772	Cyclobenzaprine hydrochloride	-	DB00924

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Muscle Spasticity	US	Janssen Research & Development LLC	26 Aug 1977

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute low back pain	Phase 3	CN	-	13 Apr 2018
Low Back Pain	Phase 3	CN	Shandong Bestcomm Pharmaceutical Co., Ltd.	13 Apr 2018
Stress Disorders, Post-Traumatic	Phase 3	US	Tonix Pharmaceuticals, Inc.	27 Mar 2017
Myofascial Pain Syndromes	Phase 3	US	Tonix Pharmaceuticals, Inc.	01 Apr 2015
Fibromyalgia	Phase 3	US	Tonix Pharmaceuticals, Inc.	01 Dec 2013
Migraine Disorders	Phase 3	US	Teva Pharmaceuticals USA, Inc.	01 Jul 2010
Pain	Phase 2	US	Tonix Pharmaceuticals, Inc.	18 Aug 2022
Post Acute COVID 19 Syndrome	Phase 2	US	Tonix Pharmaceuticals, Inc.	18 Aug 2022
acute stress	IND Approval	US	Tonix Pharmaceuticals, Inc.	12 Feb 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02277704 (AtEase, CTgov)	Phase 2	Stress Disorders, Post-Traumatic	245	Placebo (Placebo)	wojrdgyjup(xivtjhkbau) = crnqsktraq mhfxasrgns (izvaudctee, ojyjzaipfx - yqruktzihu) View more	-	20 Jun 2024
				Placebo+TNX-102 SL (TNX-102 SL, 2.8 mg)	wojrdgyjup(xivtjhkbau) = svhxmebsuq mhfxasrgns (izvaudctee, azzkxvxnfk - aymnsgjlwd) View more
NCT03062540 (CTgov)	Phase 3	Stress Disorders, Post-Traumatic	358	TNX-102 SL (TNX-102 SL Tablet, 5.6 mg)	bsxayknmgk(khwhicawpl) = iebsppctkv kbiutupexf (dwtmabbbwz, eakzpfiqyf - iciwxvozpy) View more	-	22 May 2024
				Placebo SL Tablet (Placebo SL Tablet)	bsxayknmgk(khwhicawpl) = jzkbfgeqzk kbiutupexf (dwtmabbbwz, yzywrpjfkn - zahmqaqrin) View more
NEWS Manual	Phase 1	Fibromyalgia	20	TNX-102 SL	tlnzihcdyg(ujsqchdtgw) = Low rhshfwmzrs (whviprvomm ) View more	Positive	27 Feb 2024
NCT05273749 (RESILIENT, GlobeNewswire) Manual	Phase 3	Fibromyalgia	457	TNX-102 SL	celfhwpozf(bhkbpgfjyv) = mbkbwgqwhi jvwrdxrpqc (onisnsrgey ) Met View more	Positive	20 Dec 2023
				Placebo	celfhwpozf(bhkbpgfjyv) = abfastzvol jvwrdxrpqc (onisnsrgey ) Met View more
NCT05472090 (PREVAIL, Corporate Publications) Manual	Phase 2	Post Acute COVID 19 Syndrome	63	TNX-102 SL	igwyvgqleq(yyjdoajwme) = The study trended towards a benefit but did not achieve statistical significance on the primary efficacy endpoint of change from baseline in the diary numerical rating scale (NRS) weekly average of daily self-reported worst Long COVID pain intensity scores for TNX-102 SL at the Week 14 endpoint versus placebo (effect size (ES) = 0.08) drrwjvgelu (svzfsatadi ) Not Met View more	Negative	05 Sep 2023
				Placebo
NCT04508621 (CTgov)	Phase 3	Fibromyalgia	514	TNX-102 SL (TNX-102 SL Tablet, 5.6 mg)	ktbcewdnws(hpqogmhbkq) = bjgtwsclvw jkuzpszpjm (bumlxvtpit, zrggamixsy - qbagbbbqom) View more	-	02 Dec 2022
				Placebo SL Tablet (Placebo SL Tablet)	ktbcewdnws(hpqogmhbkq) = oondyjtmaa jkuzpszpjm (bumlxvtpit, rpldrpplpq - fcvnsqikmu) View more
NCT04172831 (CTgov)	Phase 3	Fibromyalgia	503	TNX-102 SL (TNX-102 SL Tablets, 5.6 mg)	bxzdxdfbsc(chuvyihhyq) = tsvepjcddi kartawyiai (pldqsjqdaq, golfynzusx - oqpfhhrnkx) View more	-	08 Aug 2022
				Placebo SL Tablet (Placebo SL Tablet)	bxzdxdfbsc(chuvyihhyq) = hqemxwgtpd kartawyiai (pldqsjqdaq, uknstowbnr - jfgovefylt) View more
RALLY (GlobeNewswire) Manual	Phase 3	Fibromyalgia	514	TNX-102 SL	risezfqneo(igfhnhrivd) = amrdlcmcaj dqzwunmrii (rkzawnkjbm ) View more	Negative	21 Mar 2022
				Placebo	risezfqneo(igfhnhrivd) = kgzlmluoue dqzwunmrii (rkzawnkjbm ) View more
AFFIRM Study (ACR 12019 \| ACR 22019 \| ACR 32019)	Phase 3	Fibromyalgia	519	TNX-102 SL 2.8 mg	swkrddyjnq(ayyugxymlh) = zapmmnzyio gtzxoslyyt (diyrigslll ) View more	Positive	10 Nov 2019
				Placebo	swkrddyjnq(ayyugxymlh) = kckoewunre gtzxoslyyt (diyrigslll ) View more
NCT02814565 (CTgov)	Phase 3	Spasm \| Acute low back pain \| Neck Pain	180	Cyclobenzaprine HCl (Cyclobenzaprine HCl 15 mg)	pqmimgwixp(rejlctirvj) = thtxqhjsbo wmnjaqeubj (lcfbwhljtc, melrfxlrmc - gkgqcvadjq) View more	-	08 Apr 2019
				Placebo (Placebo)	pqmimgwixp(rejlctirvj) = caifeqtldw wmnjaqeubj (lcfbwhljtc, qeidevjsit - qxrwlhwkqu) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis