Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at 7th International Congress on Controversies in Fibromyalgia
Tonix Pharmaceuticals (TNXP) presented data on TNX-102 SL, their sublingual formulation of cyclobenzaprine for fibromyalgia treatment, at the 7th International Congress on Controversies in Fibromyalgia in Vienna. The drug demonstrated statistically significant improvement in reducing fibromyalgia pain in two Phase 3 studies.
TNX-102 SL has a FDA PDUFA date of August 15, 2025, and if approved, would become the first new fibromyalgia treatment in over 15 years. The drug is designed as a bedtime treatment targeting non-restorative sleep, utilizing transmucosal delivery to reduce the formation of norcyclobenzaprine.
In two 14-week Phase 3 trials, TNX-102 SL 5.6 mg met primary endpoints with significant pain reduction compared to placebo, showing good tolerability and no new safety concerns.
Tonix Pharmaceuticals (TNXP) ha presentato dati su TNX-102 SL, la loro formulazione sublinguale di ciclobenzaprina per il trattamento della fibromialgia, durante il 7° Congresso Internazionale sulle Controversie nella Fibromialgia a Vienna. Il farmaco ha dimostrato un miglioramento statisticamente significativo nella riduzione del dolore fibromialgico in due studi di Fase 3.
TNX-102 SL ha una data PDUFA della FDA fissata per il 15 agosto 2025 e, se approvato, diventerebbe il primo nuovo trattamento per la fibromialgia in oltre 15 anni. Il farmaco è progettato come trattamento da assumere prima di coricarsi, mirato a migliorare il sonno non ristoratore, utilizzando una somministrazione transmucosa per ridurre la formazione di norciclobenzaprina.
In due studi di Fase 3 della durata di 14 settimane, TNX-102 SL 5.6 mg ha raggiunto gli obiettivi primari con una significativa riduzione del dolore rispetto al placebo, mostrando una buona tollerabilità e nessuna nuova preoccupazione per la sicurezza.
Tonix Pharmaceuticals (TNXP) presentó datos sobre TNX-102 SL, su formulación sublingual de ciclobenzaprina para el tratamiento de la fibromialgia, en el 7º Congreso Internacional sobre Controversias en Fibromialgia en Viena. El medicamento demostró una mejora estadísticamente significativa en la reducción del dolor fibromialgico en dos estudios de Fase 3.
TNX-102 SL tiene una fecha PDUFA de la FDA del 15 de agosto de 2025, y si se aprueba, se convertiría en el primer nuevo tratamiento para la fibromialgia en más de 15 años. El medicamento está diseñado como un tratamiento para la hora de dormir, dirigido a mejorar el sueño no reparador, utilizando una entrega transmucosa para reducir la formación de norciclobenzaprina.
En dos ensayos de Fase 3 de 14 semanas, TNX-102 SL 5.6 mg cumplió con los objetivos primarios con una reducción significativa del dolor en comparación con el placebo, mostrando una buena tolerabilidad y sin nuevas preocupaciones de seguridad.
Tonix Pharmaceuticals (TNXP)는 비엔나에서 열린 제7회 국제 섬유근육통 논란 Congress에서 섬유근육통 치료를 위한 사이클로벤자프린의 설하 제형인 TNX-102 SL에 대한 데이터를 발표했습니다. 이 약물은 두 개의 3상 연구에서 섬유근육통 통증을 줄이는 데 통계적으로 유의미한 개선을 보였습니다.
TNX-102 SL은 FDA PDUFA 날짜가 2025년 8월 15일로 설정되어 있으며, 승인이 된다면 15년 이상 만에 처음으로 섬유근육통 치료제가 될 것입니다. 이 약물은 비회복성 수면을 목표로 하는 취침 시간 치료제로 설계되었으며, 노르사이클로벤자프린의 형성을 줄이기 위해 점막 투여를 이용합니다.
14주 동안 진행된 두 개의 3상 시험에서 TNX-102 SL 5.6 mg은 위약에 비해 통증 감소에 있어 주요 목표를 달성했으며, 좋은 내약성과 새로운 안전성 문제 없이 진행되었습니다.
Tonix Pharmaceuticals (TNXP) a présenté des données sur TNX-102 SL, leur formulation sublinguale de cyclobenzaprine pour le traitement de la fibromyalgie, lors du 7ème Congrès International sur les Controverses en Fibromyalgie à Vienne. Le médicament a montré une amélioration statistiquement significative dans la réduction de la douleur fibromyalgique dans deux études de Phase 3.
TNX-102 SL a une date PDUFA de la FDA fixée au 15 août 2025, et s'il est approuvé, il deviendrait le premier nouveau traitement pour la fibromyalgie en plus de 15 ans. Le médicament est conçu comme un traitement à prendre avant de se coucher, ciblant le sommeil non réparateur, en utilisant une administration transmucale pour réduire la formation de norcyclobenzaprine.
Dans deux essais de Phase 3 de 14 semaines, TNX-102 SL 5,6 mg a atteint les objectifs principaux avec une réduction significative de la douleur par rapport au placebo, montrant une bonne tolérance et aucune nouvelle préoccupation en matière de sécurité.
Tonix Pharmaceuticals (TNXP) hat Daten zu TNX-102 SL, ihrer sublingualen Formulierung von Cyclobenzaprin zur Behandlung von Fibromyalgie, auf dem 7. Internationalen Kongress zu Kontroversen in der Fibromyalgie in Wien präsentiert. Das Medikament zeigte eine statistisch signifikante Verbesserung bei der Reduzierung von Fibromyalgieschmerzen in zwei Phase-3-Studien.
TNX-102 SL hat einen FDA PDUFA-Termin am 15. August 2025, und wenn es genehmigt wird, wäre es die erste neue Behandlung für Fibromyalgie seit über 15 Jahren. Das Medikament ist als Nachttreatment konzipiert, das sich auf nicht-erholsamen Schlaf konzentriert und eine transmukosale Verabreichung nutzt, um die Bildung von Norcyclobenzaprin zu reduzieren.
In zwei 14-wöchigen Phase-3-Studien erreichte TNX-102 SL 5,6 mg die primären Endpunkte mit einer signifikanten Schmerzlinderung im Vergleich zu Placebo und zeigte eine gute Verträglichkeit ohne neue Sicherheitsbedenken.
- Successful Phase 3 trials meeting primary endpoints
- PDUFA date set for August 2025
- Potential first-in-class treatment for fibromyalgia in 15 years
- Novel delivery method showing superior results to oral formulation
- FDA approval still pending
- Faces competition from three existing approved products
Insights
Tonix Pharmaceuticals' TNX-102 SL represents a potentially significant advancement in fibromyalgia treatment. The drug has successfully met its primary endpoint of pain reduction in two Phase 3 clinical trials, demonstrating durable efficacy over three months. This contrasts favorably with oral cyclobenzaprine, which shows only transient benefits. The PDUFA date of August 15, 2025 establishes a clear regulatory timeline and near-term catalyst.
The fibromyalgia market represents a substantial opportunity, with innovation in over 15 years. If approved, TNX-102 SL would become the first new treatment option in this timeframe and the first in a new class of non-opioid analgesics targeting the disorder. The company's innovative approach of addressing non-restorative sleep to reduce pain provides a differentiated mechanism that could appeal to both patients and physicians seeking alternatives to current treatments.
For a company with a
The clinical data for TNX-102 SL presents a compelling case for regulatory consideration. Two separate Phase 3 trials demonstrating statistically significant improvement in pain reduction provides robust evidence of efficacy. The consistency across multiple studies strengthens the regulatory submission and suggests reproducible clinical benefit.
The mechanistic rationale - targeting non-restorative sleep to achieve pain reduction - is particularly noteworthy. This approach addresses a core symptom of fibromyalgia that contributes to pain amplification. The transmucosal delivery system's ability to bypass first-pass metabolism, reducing formation of the norcyclobenzaprine metabolite, appears to be a key differentiator from oral cyclobenzaprine, potentially explaining the enhanced durability of effect seen in clinical trials.
The safety profile, described as "generally well tolerated with an adverse event profile comparable to prior studies and with no new safety signals," suggests a favorable risk-benefit ratio. For fibromyalgia patients who have treatment options and may be inappropriately receiving opioids despite their questionable efficacy in this condition, TNX-102 SL could represent a meaningful therapeutic advance. The August 15th PDUFA date provides a clear regulatory milestone to monitor for this potential new entrant in the fibromyalgia treatment landscape.
TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia
TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two double-blind randomized Phase 3 studies
FDA Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia
If approved by FDA, it would become the first member of a new class of non-opioid analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years
CHATHAM, N.J., March 04, 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, presented data in an oral presentation at the 7th International Congress on Controversies in Fibromyalgia, held March 3-4, 2025, in Vienna, Austria. A copy of the Company’s presentation, titled “Transmucosal Sublingual Cyclobenzaprine (TNX-102 SL) Treatment of Fibromyalgia at Bedtime to Target Non-Restorative Sleep Showed Durable Pain Reduction in Two Double-Blind Randomized Phase 3 Studies” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference.
“Since fibromyalgia is a chronic pain condition, medicines to treat fibromyalgia need to provide durable benefits,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “A randomized controlled study showed that oral, swallowed cyclobenzaprine fails to provide any durable (>1 month) benefit1. In contrast, TNX-102 SL has shown statistically significant, durable activity (3 months) in reducing fibromyalgia pain in two Phase 3 studies. 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.”
Dr. Lederman continued, “TNX-102 SL is designed as a bedtime treatment to target non-restorative sleep, which in turn has shown to result in reduced pain. By providing transmucosal delivery of the tertiary amine tricyclic, TNX-102 SL results in reduced formation of the persistent active metabolite, norcyclobenzaprine (norCBP) relative to oral delivery. NorCBP accumulates after oral delivery and its potent inhibition of the norepinephrine transporter may relate to why oral cyclobenzaprine has transient (one month) activity in fibromyalgia, but not durable (three months) activity in reducing fibromyalgia pain1. Fibromyalgia, has historically been overlooked. Patients’ needs have been inadequately addressed by the three approved products, which results in many patients being prescribed chronic opioids, that are believed to be ineffective, and an actually deleterious, treatment strategy.”
TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is a potent antagonist at four post-synaptic receptors, each of which is involved in regulating sleep. TNX-102 SL is designed for rapid, transmucosal absorption and, as demonstrated in pharmacokinetic studies, bypasses first-pass hepatic metabolism resulting in greater bioavailability of cyclobenzaprine that aligns with the sleep cycle to target non-restorative sleep. The sublingual formulation also results in substantially reduced creation of the active metabolite norCyclobenzaprine (norCBP) due to the bypass of first-pass hepatic metabolism. In two 14-week double-blind, randomized, placebo-controlled Phase 3 clinical trials evaluating the safety and efficacy of TNX-102 SL as a bedtime treatment for fibromyalgia, TNX-102 SL 5.6 mg met the pre-specified primary endpoints of significantly reducing daily pain compared to placebo after 14 weeks of treatment. In both trials, TNX-102 SL was generally well tolerated with an adverse event profile comparable to prior studies and with no new safety signals observed.
About Fibromyalgia
Fibromyalgia is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization. Brain imaging studies have localized the functional disorder to the brain’s insula and anterior cingulate cortex. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including depression, anxiety, headaches and abdominal pain or cramps. Individuals suffering from fibromyalgia often struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. Fibromyalgia is now recognized as the prototypic nociplastic syndrome and as a chronic overlapping pain condition (COPC) 2-4. Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic pain. Many patients present with pain syndromes that are mixtures of the three primary types of pain. Nociplastic syndromes are associated with central and peripheral sensitization. Fibromyalgia can occur without any identifiable precipitating event. However, many fibromyalgia cases follow one or more precipitating event(s) including: post-operative pain, acute or chronic nociceptive or neuropathic pain states; recovery from an infectious illness; a cancer diagnosis or cancer treatment; a metabolic or endocrine stress; or a traumatic event. In the cases of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic Condition. In addition to fibromyalgia cases associated with other conditions or stressors, the U.S. National Academies of Sciences, Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable condition that can occur after recovery from COVID-19 in the context of Long COVID. Fibromyalgia is also recognized as a Chronic Overlapping Pain Condition, which is a group of related conditions that include chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), irritable bowel syndrome, endometriosis, low back pain, post-concussive syndrome (also known as mild traumatic brain injury), chronic Lyme Disease, chronic diabetic neuropathy and chronic post-herpetic neuralgia.
About TNX-102 SL
TNX-102 SL is a centrally acting, non-opioid investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine potently binds and acts as an antagonist at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034. The European Patent Office’s Opposition Division maintained Tonix’s European Patent EP 2 968 992 in unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine, TNX-102 SL results in higher levels of exposure during the first 2 hours after dosing and in deceased levels of the long-lived active metabolite, norcyclobenzaprine in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism. At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine. In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine.
1Carette S, et al. Arthritis Rheum. 1994, 37(1):32-40. doi: 10.1002/art.1780370106
2Fitzcharles MA, et al. Lancet. 2021;397:2098-110
3Clauw DJ. Ann Rheum Dis. Published Online First: 2024
4Kaplan CM, et al. Nat Rev Neurol. 2024;20, 347–363
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, now recognized as the prototypic nociplastic syndrome and as a chronic overlapping pain condition (COPC). 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 has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to
* 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.
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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 back
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Do not use Zembrace or Tosymra if you have:
- history of heart problems
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Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
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Zembrace and Tosymra may cause serious side effects including:
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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.
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FAQ
When is the FDA PDUFA date for TNXP's TNX-102 SL fibromyalgia treatment?
What were the Phase 3 clinical trial results for TNXP's TNX-102 SL?
How is TNXP's TNX-102 SL different from traditional cyclobenzaprine?
What potential market milestone could TNXP achieve with TNX-102 SL?
