Phase 1b/2a Clinical Trial in Early Acute Spinal Cord Injury (SCI): a Single Blinded, Randomized, Proof-of-Concept Study to Determine the Safety, Tolerability and Efficacy of TZ-161

Technophage identified a promising compound, Eletriptan hydrobromide, that intends to use as a repurposed drug, for the treatment of acute spinal cord injury (SCI) in human subjects. Eletriptan hydrobromide is a well characterized molecule, that has been clinically available for over two decades for the treatment of migraines. It presents a good and manageable safety profile, including for the regimen selected for this trial, and it is generally well tolerated, with minimal side effects. This is an important consideration to have when using repurposed drugs for the treatment of other indications. Technophage believes that the preclinical data collected, in combination with the acceptable safety profile of Eletriptan hydrobromide, support its use as a repurposed drug for the treatment of SCI in humans.

Start Date01 Jan 2025

Sponsor / Collaborator

TechnoPhage SA

[+1]

TCTR20220119005

/ Not yet recruitingPhase 1

Bioequivalence study of an open-label, randomized, two-way crossover design with two-period, two-treatment, two-sequence of test product eletriptan 40 mg film-coated tablets and reference product (RELPAX (TABLETS 40 MG)) in Thai healthy volunteers under fasting condition

Start Date31 Mar 2022

Sponsor / Collaborator

Service Pharmacy

NCT01653522

/ WithdrawnNot ApplicableIIT

The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine

The purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine.

Start Date01 Jul 2012

Sponsor / Collaborator

The Cleveland Clinic Foundation

100 Clinical Results associated with Eletriptan Hydrobromide

100 Translational Medicine associated with Eletriptan Hydrobromide

100 Patents (Medical) associated with Eletriptan Hydrobromide

1,356

Literatures (Medical) associated with Eletriptan Hydrobromide

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Lost earnings among triptan non-responders in the general population of Denmark: a measure of disproportionate migraine-attributed burden and of unrecognised and unmet treatment need

Article

Author: Spanggaard, Maria ; Hansen, Jakob Møller ; Steiner, Timothy J. ; Ashina, Messoud ; Hauberg, Daniel Sloth ; Stallknecht, Sandra Benkjer ; Lønberg, Ulla Sofie ; Hansen, Thomas Folkmann ; Olsen, Jens

AIMS:

Migraine leads to substantial healthcare utilization and associated costs. However, much higher costs are attributed to lost productivity. The impact of effective migraine treatment on these costs, at the individual level, has not been well established. Even less known is the impact of treatment failure. The objective of this study was to assess lost earnings as a measure of migraine-attributed burden among triptan non-responders in Denmark.

MATERIALS AND METHODS:

We used data from the Danish National Prescription Register and Danish Income Statistics Register over the 27-year period 1995-2021. We identified 4,979 triptan non-responders (85.9% female) and matched them for sex, age and region of residence with 14,292 continuing users of triptans (triptan responders) and 13,592 individuals from the background population (triptan never-users). We then estimated average annual individual earnings, and compared those among triptan non-responders, from 3 years prior to and 10 years after their last triptan redemption, with those among their matched triptan responders and triptan never-users over the same periods.

RESULTS:

Triptan non-responders earned significantly less than both their matched triptan responders and their matched triptan never-users. The earnings gap was evident even 3 years prior to the last triptan prescription (€4,344 and €4,356 respectively). This gap widened substantially over time, so that average cumulative earnings over the 14-year period of follow-up for each triptan non-responder were €93,684 less than those of responders and €99,485 less than those of never-users.

LIMITATIONS:

There are uncertainties with regard to the reasons for triptan discontinuation (whether non-response or otherwise), and to lack of diagnostic confirmation of migraine.

CONCLUSIONS:

Triptan non-response represents failure of currently available acute treatment options. It is associated with substantial and cumulative lost earnings, highlighting a disproportionate economic burden. These findings underscore the potential economic benefit of recognizing, and rectifying, unmet treatment needs in migraine management.

03 Apr 2025·Expert Review of Neurotherapeutics

The burden of migraine in Mexico: a database analysis of migraine-related visits to emergency departments in Mexico’s Ministry of Health (MMoH) hospitals

Article

Author: Osorio-Hernandez, Mariana ; Marfil, Alejandro ; Caballero, Nohemi ; Partida Medina, Luis Roberto ; Gudiño Castelazo, Manuel ; Pastrana, Martha Eugenia ; Sanchez Trujillo, Luis Arturo ; Julian, Guilherme Silva ; Galnares Olalde, Javier Andres

BACKGROUND:

The burden of migraine in Mexican Emergency Department (ED) settings remains understudied. This study aimed to determine the frequency of migraine-related ED visits within the ED Mexican Ministry of Health's (MMoH) database and analyze their demographics and treatment patterns.

RESEARCH DESIGN AND METHODS:

This retrospective study analyzed MMoH database of ED visits between 2013 and 2022. Visits with migraine diagnosis were selected using ICD-10 codes. Demographic characteristics, geographical location, and time of consultation were described, medication use patterns were analyzed.

RESULTS:

Between 2013 and 2022, there were 1,022,450 reported ED visits related to primary headache (0.6% of all ED visits), there were 179,618 migraine-related ED visits (19% of all headache visits). Females represented 78% of visits. Visits peaked in 2014 (20,066) and were the lowest in 2019 (8,273). Medication was used in 21% of visits, NSAIDs being the most frequent (15%). Triptan use was low (0.04% of all migraine visits).

CONCLUSION:

Our results highlight the significant burden of migraines on Mexico's healthcare system and the importance of considering age and sex in the approach to migraine ED visits. An update in therapeutic strategies for migraine in Mexico is needed to improve patient outcomes.

01 Apr 2025·ANNALS OF INTERNAL MEDICINE

Pharmacologic Treatment of Acute Attacks of Episodic Migraine: A Systematic Review and Network Meta-analysis for the American College of Physicians

Review

Author: Dobrescu, Andreea ; Feyertag, Johanna ; Persad, Emma ; Thaler, Kylie ; Gartlehner, Gerald ; Neubauer, Camilla ; Nowak, Claus ; Chapman, Andrea ; Gadinger, Arianna ; Wagner, Gernot ; Klerings, Irma

BACKGROUND:

Migraine is common, affecting 15% of Americans.

PURPOSE:

To compare benefits and harms of pharmacologic treatments for acute attacks of episodic migraine in adults and assess cost-effectiveness.

DATA SOURCES:

Three electronic databases searched to October 2024, gray literature, and reference lists.

STUDY SELECTION:

Two investigators independently selected English-language randomized trials.

DATA EXTRACTION:

Single reviewer data extraction with second review. Dual independent risk of bias and certainty of evidence (COE) assessment.

DATA SYNTHESIS:

Twenty-one head-to-head and 165 placebo-controlled trials were included in meta-analyses and network meta-analyses. Triptans were more effective than acetaminophen (low COE) and nonsteroidal anti-inflammatory drugs (NSAIDs) (high COE) for pain outcomes at 2 hours and pain freedom up to 48 hours. Triptan and acetaminophen combinations were more effective than acetaminophen alone (moderate COE) for pain outcomes at 2 hours and pain freedom up to 48 hours but not more than triptans alone (low COE). Triptan and NSAID combinations were more effective for pain outcomes at 2 hours and pain freedom up to 48 hours compared with acetaminophen (low COE), gepants (low COE), NSAIDs (high COE), and triptan monotherapy (moderate COE). Triptan regimens, however, often had a higher risk for adverse events. One study found triptans more cost-effective than ditans and gepants.

LIMITATIONS:

Harms assessment was limited to randomized trials. Many comparisons lacked sufficient evidence to draw conclusions.

CONCLUSION:

Triptans and combinations of triptans were more effective than NSAID and acetaminophen alone.

PRIMARY FUNDING SOURCE:

American College of Physicians. (PROSPERO: CRD42023441146).

News (Medical) associated with Eletriptan Hydrobromide

16 Apr 2025

·www.globenewswire.com

Tonix Pharmaceuticals Announces Oral Presentation and Panel Participation at the World Vaccine Congress Washington 2025

CHATHAM, N.J., April 16, 2025 (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 that the Company will deliver an oral presentation and lead a panel discussion at the World Vaccine Congress Washington 2025, which will be held in Washington, D.C., April 22-24, 2025. A copy of the Company’s presentation will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the World Vaccine Congress website here. Presentation Details Presenter:Farooq Nasar, PhD, Senior Principal Investigator, Research and Development Center, Tonix PharmaceuticalsSession:Emerging & Re-emerging DiseasesTitle:A Novel Single-Dose, Attenuated Live, Minimally Replicative Mpox VaccineLocation:Room 202BDate:Wednesday, April 23, 2025Time:10:10 a.m. Panel Details Moderator:Zeil Rosenberg, M.D., M.P.H., Executive Vice President, Medical, Tonix PharmaceuticalsSession:Emerging & Re-emerging DiseasesTitle:Mpox and Smallpox Threats: Vaccine Development and Biosecurity PolicyLocation:Room 202BDate:Wednesday, April 23, 2025Time:3:25 p.m. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified 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’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. 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; their efficacy and safety have not been established and have 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, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, 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) 799-8599 Peter VozzoICR Healthcarepeter.vozzo@icrhealthcare.com (443) 213-0505 Media Contact Ray Jordan Putnam Insights ray@putnaminsights.com (949) 245-5432 Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age. Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes backsevere tightness, pain, pressure, or heaviness in your chest, throat, neck, or jawpain or discomfort in your arms, back, neck, jaw or stomachshortness of breath with or without chest discomfortbreaking out in a cold sweatnausea or vomitingfeeling lightheaded Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use Zembrace or Tosymra if you have: history of heart problemsnarrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)uncontrolled high blood pressurehemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.had a stroke, transient ischemic attacks (TIAs), or problems with blood circulationsevere liver problemstaken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.an allergy to sumatriptan or any of the components of Zembrace or Tosymra Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert. Zembrace and Tosymra may cause serious side effects including: changes in color or sensation in your fingers and toessudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fevercramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feetincreased blood pressure including a sudden severe increase even if you have no history of high blood pressuremedication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.hives (itchy bumps); swelling of your tongue, mouth, or throatseizures even in people who have never had seizures before The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only). Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider. This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633. You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Fast TrackPhase 3VaccinePhase 2Breakthrough Therapy

27 Mar 2025

·www.globenewswire.com

Tonix Pharmaceuticals Announces Presentation at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting

CHATHAM, N.J., March 27, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer, will present a poster at the AAPM 2025 Annual Meeting, PainConnect, in Austin, Texas on April 5, 2025, at 11:45 a.m. CT. The meeting will take place from April 3-6, 2025. A copy of the Company’s poster will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the conference website. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified 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 infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. 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; their efficacy and safety have not been established and have 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, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, 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) 799-8599 Peter VozzoICR Healthcarepeter.vozzo@icrhealthcare.com (443) 213-0505 Media Contact Ray JordanPutnam Insightsray@putnaminsights.com(949) 245-5432 Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age. Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes backsevere tightness, pain, pressure, or heaviness in your chest, throat, neck, or jawpain or discomfort in your arms, back, neck, jaw or stomachshortness of breath with or without chest discomfortbreaking out in a cold sweatnausea or vomitingfeeling lightheaded Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use Zembrace or Tosymra if you have: history of heart problemsnarrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)uncontrolled high blood pressurehemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.had a stroke, transient ischemic attacks (TIAs), or problems with blood circulationsevere liver problemstaken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.an allergy to sumatriptan or any of the components of Zembrace or Tosymra Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert. Zembrace and Tosymra may cause serious side effects including: changes in color or sensation in your fingers and toessudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fevercramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feetincreased blood pressure including a sudden severe increase even if you have no history of high blood pressuremedication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.hives (itchy bumps); swelling of your tongue, mouth, or throatseizures even in people who have never had seizures before The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only). Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider. This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633. You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Phase 2Fast TrackPhase 3Vaccine

13 Mar 2025

·www.globenewswire.com

Tonix Pharmaceuticals Announces Presentation at BIO-Europe Spring 2025

CHATHAM, N.J., March 13, 2025 (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 that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the 2025 BIO-Europe Spring Convention being held March 17-19, 2025, in Milan, Italy. The Company’s presentation will take place on Monday, March 17, 2025, at 2:00 p.m. CET in the Exhibit Hall Stage Room of the Allianz MiCo Central Building. Dr. Lederman’s presentation will focus on TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. The U.S. Food and Drugs Administration (FDA) has set a PDUFA goal date of August 15, 2025 for a decision on marketing authorization. TNX-102 SL now has the potential to be the first new treatment option for fibromyalgia patients in 15 years. To schedule a meeting with the Company’s management at the convention, please submit a meeting request through the BIO One-on-One Partnering™ system or contact brandon.weiner@icrhealthcare.com. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified 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 infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. 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; their efficacy and safety have not been established and have 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) 799-8599 Peter VozzoICR Healthcarepeter.vozzo@icrhealthcare.com (443) 213-0505 Media Contact Ray JordanPutnam Insightsray@putnaminsights.com(949) 245-5432 Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age. Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes backsevere tightness, pain, pressure, or heaviness in your chest, throat, neck, or jawpain or discomfort in your arms, back, neck, jaw or stomachshortness of breath with or without chest discomfortbreaking out in a cold sweatnausea or vomitingfeeling lightheaded Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use Zembrace or Tosymra if you have: history of heart problemsnarrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)uncontrolled high blood pressurehemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.had a stroke, transient ischemic attacks (TIAs), or problems with blood circulationsevere liver problemstaken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.an allergy to sumatriptan or any of the components of Zembrace or Tosymra Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert. Zembrace and Tosymra may cause serious side effects including: changes in color or sensation in your fingers and toessudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fevercramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feetincreased blood pressure including a sudden severe increase even if you have no history of high blood pressuremedication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.hives (itchy bumps); swelling of your tongue, mouth, or throatseizures even in people who have never had seizures before The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only). Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider. This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633. You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Fast TrackPhase 3Phase 2

100 Deals associated with Eletriptan Hydrobromide

External Link

KEGG	Wiki	ATC	Drug Bank
D01973	Eletriptan Hydrobromide	N02CC06	DB00216

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	Japan	Viatris Pharmaceutical Co. Ltd.	11 Apr 2002
Migraine Disorders	Japan	Pfizer Inc.	11 Apr 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Migraine With Aura	Phase 3	Belgium	Viatris, Inc.	01 Mar 2000
Migraine With Aura	Phase 3	Czechia	Viatris, Inc.	01 Mar 2000
Migraine With Aura	Phase 3	Denmark	Viatris, Inc.	01 Mar 2000
Migraine With Aura	Phase 3	France	Viatris, Inc.	01 Mar 2000
Migraine With Aura	Phase 3	Germany	Viatris, Inc.	01 Mar 2000
Migraine With Aura	Phase 3	Greece	Viatris, Inc.	01 Mar 2000
Migraine With Aura	Phase 3	Hungary	Viatris, Inc.	01 Mar 2000
Migraine With Aura	Phase 3	Italy	Viatris, Inc.	01 Mar 2000
Migraine With Aura	Phase 3	Netherlands	Viatris, Inc.	01 Mar 2000
Migraine With Aura	Phase 3	Norway	Viatris, Inc.	01 Mar 2000

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01086358 (CTgov)	Phase 4	Migraine Disorders	60	almotriptan+eletriptan+Treximet+rizatriptan+sumatriptan+zolmitriptan+triptan (Arm 1 - Triptan)	biwpcdinqv(hpmwsofqbi) = jgozkmjkku opjewcwqwz (mmiyeeeuti, irptctaauu - pgypajmqva) View more	-	01 May 2018
				Naproxen Sodium (Treximet)+Sumatriptan (Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm)	biwpcdinqv(hpmwsofqbi) = sxbxfvyrdx opjewcwqwz (mmiyeeeuti, kpczolqbfc - pqtjikwzoq) View more
NCT01859481 (Pubmed \| Cephalalgia)	Phase 3	Migraine Disorders	971	Eletriptan 40 mg	gtrzhrousa(znhldfzrbh) = vshaliqhqm pgcgkzihff (miggnthovh ) View more	Positive	01 Feb 2014
				Eletriptan 80 mg	gtrzhrousa(znhldfzrbh) = hdsmfdpqtn pgcgkzihff (miggnthovh ) View more

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