A Randomized, Parallel-Group, Single-Attack, Open-Label Study to Evaluate the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine (ATOM).

In a real-world population of adults with migraine, the investigators would like to investigate whether 12.5 mg almotriptan is non-inferior to 50 mg ubrogepant in terms of pain freedom at 2 hours after drug intake.

Start Date30 Jun 2022

Sponsor / Collaborator

Danish Headache Center

EUCTR2021-001087-24-DK / Unknown statusPhase 4IIT

A Randomized, Parallel-Group, Single-Attack, Open-Label Study to Evaluate the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine (ATOM). - ATOM

Start Date10 Jun 2021

Sponsor / Collaborator

Danish Headache Center

100 Clinical Results associated with Almotriptan Malate

100 Translational Medicine associated with Almotriptan Malate

100 Patents (Medical) associated with Almotriptan Malate

267

Literatures (Medical) associated with Almotriptan Malate

01 Mar 2025·CNS & Neurological Disorders-Drug Targets

Recent Development of Zolmitriptan Formulation in Migraine Therapy: Production, Metabolism and Pharmaceutical Aspects

Article

Author: Alsufyani, Mohammed Omair ; Alhothali, Khadijah Oudah R ; Rashid, Mohammad ; Al-Jarallah, Abdulrahman Mohammed ; Alqethami, Mohammed Ghanim ; Dewangan, Rikeshwer Prasad ; Husain, Asif ; Hakme, Mohammed Japer Mohammed ; Bano, Farha ; Aba Alkhayl, Faris F.

The triptans class of pharmaceuticals, which was created to treat acute migraine, is made up of indole-containing drugs that bind to a subset (1B/1D) of 5-hydroxytryptamine receptors and are agonists of serotonin receptors. At the moment, naratriptan, eletriptan, zolmitriptan, rizatriptan, almotriptan, and frovatriptan are the seven types of triptans available on the market. Among these are the FDA-approved triptans, Zolmitriptan and Sumatriptan, which are selective serotonin (5-hydroxytryptamine) agonists. Zolmitriptan, a synthetic tryptamine derivative and a well-known member of the triptan family, is available as an orally disintegrating tablet, nasal spray, and tablet. There are melt formulations of rizatriptan and zolmitriptan available on the market that are easier to use and absorb, comparable to regular pills. Recently, the FDA approved zolmitriptan, a medication with tolerability comparable to sumatriptan. Whereas zolmitriptan is only available as an oral melt or tablet, sumatriptan is available as a nasal spray, oral preparation, or self-injectable kit. The only known antimigraine drugs that were widely utilized before the triptan period were ergotamine and dihydroergotamine. However, zolmitriptan binds to plasma proteins only 25% of the time because of significant first-pass degradation. Researchers have looked into fresh ideas for solving this issue and innovations to overcome its pharmacokinetic difficulties. This article emphasizes the role of zolmitriptan in the treatment of migraines, highlighting its pharmacological properties, production, metabolism, and structural features.

01 Aug 2024·Pain and Therapy

Rizatriptan as an Over-the-Counter Triptan in the Treatment of Migraine Attacks

Review

Author: Göbel, Hartmut ; Göbel, Carl H ; Heinze, Axel ; Cirkel, Anna

Around 91% of migraine patients use over-the-counter medicines to treat attacks, often without further treatment or medical consultation. This therapeutic principle is established in most countries, regardless of how the healthcare system is otherwise structured or financed. Using Germany as an example, the basis for an expansion of attack therapy with rizatriptan as an over-the-counter triptan is described. To achieve the best possible tolerability and safety in the context of self-medication, the lowest possible dose should be selected to provide the most favourable tolerability and safety profile in the context of self-medication through low dosages. The lowest approved dose of rizatriptan is 5 mg. This was investigated in three randomized controlled trials with 752 patients. The results show that rizatriptan at a dose of 5 mg is more effective than the triptans naratriptan 2.5 mg, almotriptan 12.5 mg and sumatriptan 50 mg, which were previously available for self-medication in Germany. There was no significant difference in the frequency of adverse events with rizatriptan 5 mg compared to placebo. Rizatriptan 5 mg does not have a higher side effect potential than sumatriptan 50 mg, which is already exempt from the prescription requirement. The reasons given show that rizatriptan in a dose of 5 mg for the treatment of acute migraine attacks fulfils the requirements for a transfer from prescription to pharmacy-only status at least as well as sumatriptan 50 mg, naratriptan 2.5 mg and almotriptan 12.5 mg. From a clinical care perspective, it is desirable for affected patients to have other options available for self-medication. Non-responders to other substances also have a further treatment option with rizatriptan 5 mg, with the same or even better risk-benefit profile, to treat migraine attacks safely, effectively and in a tolerable manner as part of self-medication.

01 Jan 2024·Handbook of clinical neurology

The 5-HT1B and 5-HT1D agonists in acute migraine therapy: Ergotamine, dihydroergotamine, and the triptans

Review

Author: Whealy, Mark ; Becker, Werner J

The advent of the triptans revolutionized acute migraine treatment. The older migraine-specific drugs, the ergot alkaloids (ergotamine and dihydroergotamine), also relieve migraine attacks through agonism at the 5-HT_1B and 5-HT_1D receptors, but the triptans have much greater specificity for these receptors. Unlike the ergot alkaloids, the triptans do not activate many other receptor types, and therefore are much better tolerated. This reduction in side effects greatly enhanced their clinical utility as it allowed a far greater proportion of patients to take a full therapeutic dose. As a result, the clinical use of ergotamine is minimal today, although dihydroergotamine still has a significant clinical role. There is extensive evidence that the seven triptans available today, sumatriptan, zolmitriptan, rizatriptan, eletriptan, naratriptan, almotriptan, and frovatriptan, are effective in the acute treatment of migraine. Available formulations include oral tablets, orally dissolving tablets, subcutaneous injections, nasal sprays, and in some countries, rectal suppositories. For optimal benefit, therapy needs to be individualized for a given patient both regarding the triptan chosen and the formulation. This chapter discusses the ergot alkaloids and the triptans, including mechanism of action, evidence for efficacy, clinical use, and adverse effects.

News (Medical) associated with Almotriptan Malate

03 Dec 2024

·www.globenewswire.com

Tonix Pharmaceuticals Announces Expansion of Leadership Team with Two Strategic Hires

Tonix appoints two executives with decades of experience successfully launching and commercializing new CNS products Bradley Raudabaugh, MBA, joins as Vice President, Marketing, bringing over 25 years of marketing, sales and product planning experience to Tonix Errol Gould, Ph.D., joins Tonix as Vice President, Medical Affairs, with over 25 years of experience in R&D and medical affairs across a wide range of therapeutic areas, including fibromyalgia New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia submitted to FDA in October 2024; NDA acceptance expected December 2024; Fast Track designation previously granted by FDA; FDA decision on approval expected 2025 If approved by FDA, TNX-102 SL would be the first member of a new class of analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years CHATHAM, N.J., Dec. 03, 2024 (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 the expansion of its leadership team to support the launch of TNX-102 SL for the management of fibromyalgia. Bradley Raudabaugh, MBA, has been appointed Vice President, Marketing, and Errol Gould, Ph.D., has been appointed Vice President, Medical Affairs. “We have further strengthened our leadership team with these two strategic hires as we continue to develop our commercial strategies and enhance the potential of our pipeline products. We look forward to leveraging their leadership capabilities and commercial experience as Tonix prepares for the launch of TNX-102 SL for the management of fibromyalgia,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Bradley’s experience in spearheading successful product launches and his deep commercial insights provide us a crucial asset as we prepare to receive a decision from the U.S. Food and Drug Administration (FDA) for our TNX-102 SL NDA in 2025. Similarly, we believe Errol’s experience from working with Tonix since March 2024 as a medical affairs consultant and his vast and well-rounded experience in the development of products in a variety of therapeutic areas will help us continue to build our reputation within the medical community.” Mr. Raudabaugh offers significant leadership experience in building and launching major brands. Most recently, he was the Vice President of Product Strategy at Axsome Therapeutics, where he led the strategic go-to-market planning across five products/indications in psychiatry and neurology. Earlier at Axsome, he led their first commercial launch with Auvelity for the treatment of major depressive disorder, and the integration of Sunosi upon acquisition for the treatment of excessive daytime sleepiness in patients with narcolepsy and sleep apnea. Prior to Axsome, Bradley has held roles of increasing responsibility across marketing, sales, and market access at Insmed, Amgen, Teva, and AstraZeneca. Mr. Raudabaugh holds a Master of Business Administration from the Olin Business School at Washington University in St. Louis and a Bachelor of Arts from Louisiana State University. “This is an exciting time to be joining Tonix as it prepares to receive an FDA decision on its NDA for TNX-102 SL for the management of fibromyalgia,” said Mr. Raudabaugh. “I am ecstatic to work with the Tonix team. We have an opportunity to bring to patients and clinicians the first newly approved drug for fibromyalgia in more than 15 years.” Dr. Gould has over 25 years of experience in research and development and medical affairs across multiple therapeutic areas, including neurology, pain, and sleep, and worked with Tonix as a medical affairs consultant since March 2024. Since 2022, Dr. Gould has served as Head of Medical Affairs in a consultant role at Enalare Therapeutics, developing medical strategy, external messaging and publication plans for its novel respiratory stimulant candidate, ENA-001. Previously, he spent over eight years at Currax Pharmaceuticals, where he ultimately served as Head of Medical and Scientific Affairs. In this role, he led clinical and non-clinical research, developed U.S. and global medical affairs strategies and oversaw medical information for all marketed products. Earlier in his career, Dr. Gould had various medical affairs roles at Synchrony Healthcare Communications, Nuvo Research and Endo Pharmaceuticals. Dr. Gould began his career at GlaxoSmithKline as the Assistant Director in the Metabolism Therapeutic Area and later served on secondment as an Associate Product Manager for the Diabetes Franchise. Dr. Gould holds a Ph.D. in pharmacology from West Virginia University and a Bachelor of Science in biochemistry from the University of Massachusetts-Amherst. He also served as a Research Associate at Hahnemann University and as a Post-Doctoral Fellow/Research Associate at the University of Virginia. “I look forward to partnering with the Tonix team and building upon the Company’s successes to support TNX-102 SL as well as provide medical and strategic insight across the entire Tonix portfolio,” said Dr. Gould. 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. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. We expect an FDA decision on the acceptance of the NDA for review and a PDUFA date in December 2024 and if accepted, a decision on NDA approval in August 2025 for standard review. 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 U.S. National Institute of Drug Abuse and Addiction. 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 the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and 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) 904-8182 Peter VozzoICR Healthcarepeter.vozzo@westwicke.com (443) 213-0505 Media Contact Ray JordanPutnam Insightsray@putnaminsights.com(949) 245-5432 Indication and UsageZembrace® 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 3Fast TrackExecutive ChangePhase 2NDA

19 Sep 2024

·www.fiercepharma.com

New migraine drugs less effective than previous generation of triptan meds: BMJ study

A meta-analysis of 137 trials of migraine drugs indicates that the newest class of treatments are less effective than the previous generation of triptan drugs in relieving acute headaches. A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines.What's more, the newer drugs are no more effective in treating migraines than traditional headache remedies such as Tylenol, ibubrofen and aspirin, according to The BMJ's analysis.The study, a meta-analysis of 137 trials that together enrolled nearly 90,000 patients, indicates that the most effective treatments for migraine come from the triptan class. In head-to-head comparisons of the 17 drugs covered in the study, triptans demonstrated the best efficacy within 2 hours of use, led by eletriptan, which also delivered the best-sustained relief over 24 and 48 hours, according to the analysis.Eletriptan was brought to the market by Pfizer in 2002 and sold under the brand name Relpax. The next most effective medicines in providing relief at 2 hours were the following triptans (in order of performance): rizatriptan, sumatriptan and zolmitriptan. Rizatriptan is sold by Organon as Maxalt. GSK sells sumatriptan as Imitrex and AstraZeneca markets zolmitriptan as Zomig.“Triptans are currently widely underused, and access to the most effective triptans should be promoted globally and international guidelines updated accordingly,” the authors wrote. The BMJ analysis also concluded that the newest class of migraine treatments—which are called calcitonin gene-related peptide receptor (CGRP) antagonists—should only be used after traditional headache meds.“While the recent introduction of lasmiditan (Reyvow), rimegepant (Nurtec), and ubrogepant (Ubrelvy) has expanded options for the acute treatment of migraine, the high cost of these newer drugs, along with the substantial adverse effects of lasmiditan, suggest their use as third-line options, after the less expensive, similarly efficacious, second-line options," the authors wrote.While the BMJ study focused on acute treatment of migraines, new CGRP treatments have also been approved as preventatives. Nurtec pills, for example, were approved in 2021 for use every other day to ward off potential migraines. Much hope has been pinned on the effectiveness of CGRP drugs. In 2022, Pfizer spent $11.6 billion in a buyout of Biohaven to gain Nurtec, which rolled up sales of $928 million last year. Meanwhile, Ubrelvy, which was approved in 2019, generated $815 million in sales.Several other CGRPs—all approved in 2018 for the prevention of migraines—also remain formidable. Eli Lilly’s Emgality generated $678 million in sales last year, while Teva’s Ajovy pulled in $435 million and Amgen’s Aimovig collected $303 million. Besides those drugs, Lundbeck's Vyepti won approval in 2020 and generated about $250 million last year.

Drug ApprovalAcquisitionClinical Result

19 Sep 2024

·www.globenewswire.com

Tonix Pharmaceuticals Announces Issuance of U.S. Patent by the United States Patent and Trademark Office Covering the Intranasal Delivery of FDA-Approved Tosymra® to Treat Migraines

New patent expected to expire in 2030 Tosymra® (sumatriptan nasal spray) 10mg is indicated and marketed for the acute treatment of migraine in adults CHATHAM, N.J., Sept. 19, 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 that the United States Patent and Trademark Office issued U.S. Patent No. 12,090,139 to the Company on September, 17, 2024. The patent, entitled “Formulations Comprising Triptan Compounds”, claims a pharmaceutical composition, a method of treating migraine via intranasal administration, and an intranasal delivery system for Tosymra®. This patent, excluding possible patent term extensions, is expected to expire in 2030. “We believe this patent further solidifies Tosymra® in the market as a differentiated drug with a differentiated administration method,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “This new patent targets specific delivery and composition. We are thrilled to have these additional issued patent claims, which add to the intellectual property protection existing for Tosymra®.” About Migraine Nearly 40 million people in the United States suffer from migraine1 and it has been recognized as the second leading cause of disability in the world2,3. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia)4. 1Law, H. Z., Chung, M. H., Nissan, G., Janis, J. E., & Amirlak, B. (2020). Hospital Burden of Migraine in United States Adults: A 15-year National Inpatient Sample Analysis. Plastic and reconstructive surgery. Global open, 8(4), e2790. https://doi-org.libproxy1.nus.edu.sg/10.1097/GOX.0000000000002790 2GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2018;17(11):954-976. 3Steiner, T.J., Stovner, L.J., Jensen, R. et al. Lifting the Burden: the Global Campaign against Headache. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain 21, 137 (2020). 4Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to submit a New Drug Application (NDA) to the FDA in October 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has 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. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development 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, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA) 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, instrumental in progressing this development. 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. 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 Ray JordanPutnam Insightsray@putnaminsights.com(949) 245-5432 Tosymra® (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of 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 Tosymra is 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 is done and shows no problem. Do not use Tosymra if you have: history of heart problemsnarrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)uncontrolled high blood pressuresevere liver problemshemiplegic or basilar migraines. If you are not sure if you have these, ask your healthcare provider.had a stroke, transient ischemic attacks (TIAs), or problems with blood circulationtaken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider if you are not sure if your medicine is listed above.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 ingredient in Tosymra Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. 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. 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 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 Tosymra include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation. 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 Tosymra. For more information, ask your provider. This is the most important information to know about 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 www.tonixpharma.com or call 1-888-650-3789. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. INDICATION AND USAGETosymra is a prescription medicine used to treat acute migraine headaches with or without aura in adults. Tosymra is not used to treat other types of headaches such as hemiplegic or basilar migraines or cluster headaches. Tosymra is not used to prevent migraines. It is not known if Tosymra is safe and effective in children under 18 years of age.

Fast TrackPhase 2Phase 3

100 Deals associated with Almotriptan Malate

External Link

KEGG	Wiki	ATC	Drug Bank
D02825	Almotriptan Malate	N02CC05	DB00918

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	US	Janssen Pharmaceuticals, Inc.	07 May 2001

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute migraine	Phase 3	-	Ortho-mcneil Neurologics, Inc.	01 Jul 2003
Acute migraine	Phase 3	-	Janssen Ortho LLC	01 Jul 2003

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)	oafttnxgig(xwxnnimylm) = cdqafrrwlk nixjjxskzs (klfzgomgpw, npvwnxivxz - geuphrbhgh) View more	-	01 May 2018
				Naproxen Sodium (Treximet)+Sumatriptan (Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm)	oafttnxgig(xwxnnimylm) = vujuxqaqbg nixjjxskzs (klfzgomgpw, aspirwrkig - jgjcvdmykd) View more
NCT00257010 (CTgov)	Phase 3	Migraine Disorders	447	Almotriptan Malate	avbcuvvkgs(coyklbzhmc) = itotlxoeaw twyrohuejr (pssazjffzt, digeilemzq - qtkwtzccfb) View more	-	06 Dec 2013
NCT00210483 (Pubmed \| Headache)	Phase 3	-	866	Almotriptan 6.25 mg	xgmregucwg(jpawkjxoim) = cqobboprgk zmxnlevoqm (ymuvfxipsm ) View more	Positive	01 Oct 2008
				Almotriptan 12.5 mg	xgmregucwg(jpawkjxoim) = ikyefbyhxa zmxnlevoqm (ymuvfxipsm ) View more
NCT00212823 (AIMS, Pubmed \| Headache)	Phase 4	Migraine Disorders	1,450	almotriptan (Early Treatment (ET))	(iuqswjvdjt) = 1.1% and 0.7% in the ET and ST groups, respectively ccjsxexinf (sbsobtucnw ) View more	-	01 Apr 2007
				almotriptan (Standard Treatment (ST))
NCT00210509 (AEGIS, Pubmed \| Headache)	Phase 4	Migraine Disorders	378	Almotriptan 12.5 mg	xqkdvqoywi(tfsrcgbieh) = ziwajbhrvl xhxcgufuyv (jmfjrnlwyo ) View more	Positive	01 Feb 2007
				Placebo	xqkdvqoywi(tfsrcgbieh) = vdhrxvkyun xhxcgufuyv (jmfjrnlwyo ) View more

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