Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval for TNX-102 SL for Fibromyalgia
Tonix Pharmaceuticals (TNXP) announced that the FDA has set a PDUFA goal date of August 15, 2025, for their TNX-102 SL marketing approval decision for fibromyalgia treatment. The drug, granted Fast Track designation in July 2024, is a non-opioid, centrally-acting analgesic that could become the first new fibromyalgia treatment in over 15 years.
The NDA submission is supported by two successful Phase 3 trials: RELIEF (completed December 2020) and RESILIENT (completed December 2023), both showing statistically significant pain reduction compared to placebo (p=0.010 and p=0.00005 respectively). TNX-102 SL demonstrated favorable tolerability with minimal adverse events, primarily consisting of temporary tongue numbness at the administration site.
Tonix Pharmaceuticals (TNXP) ha annunciato che la FDA ha fissato una data obiettivo PDUFA del 15 agosto 2025 per la decisione di approvazione del marketing del loro TNX-102 SL per il trattamento della fibromialgia. Il farmaco, che ha ricevuto la designazione Fast Track a luglio 2024, è un analgesico non oppioide ad azione centrale che potrebbe diventare il primo nuovo trattamento per la fibromialgia in oltre 15 anni.
La sottomissione della NDA è supportata da due trial di fase 3 di successo: RELIEF (completato a dicembre 2020) e RESILIENT (completato a dicembre 2023), entrambi mostrano una riduzione del dolore statisticamente significativa rispetto al placebo (p=0.010 e p=0.00005 rispettivamente). TNX-102 SL ha dimostrato una tollerabilità favorevole con eventi avversi minimi, costituiti principalmente da una temporanea intorpidimento della lingua nel sito di somministrazione.
Tonix Pharmaceuticals (TNXP) anunció que la FDA ha establecido una fecha objetivo PDUFA del 15 de agosto de 2025 para la decisión de aprobación de comercialización de su TNX-102 SL para el tratamiento de la fibromialgia. El medicamento, que recibió la designación de Fast Track en julio de 2024, es un analgésico no opioide de acción central que podría convertirse en el primer nuevo tratamiento para la fibromialgia en más de 15 años.
La presentación de la NDA está respaldada por dos ensayos de fase 3 exitosos: RELIEF (completado en diciembre de 2020) y RESILIENT (completado en diciembre de 2023), ambos mostrando una reducción del dolor estadísticamente significativa en comparación con placebo (p=0.010 y p=0.00005 respectivamente). TNX-102 SL demostró una tolerabilidad favorable con eventos adversos mínimos, que consisten principalmente en un entumecimiento temporal de la lengua en el sitio de administración.
Tonix Pharmaceuticals (TNXP)는 FDA가 섬유근육통 치료를 위한 TNX-102 SL의 마케팅 승인 결정을 위해 2025년 8월 15일을 목표 날짜로 설정했다고 발표했습니다. 이 약물은 2024년 7월에 패스트트랙 지정 을 받았으며, 비오피오이드, 중추 작용 진통제로 15년 이상 동안의 첫 새로운 섬유근육통 치료제가 될 수 있습니다.
NDA 제출은 두 개의 성공적인 3상 시험인 RELIEF(2020년 12월 완료)와 RESILIENT(2023년 12월 완료)에 의해 지원되며, 두 시험 모두 위약 대비 통증 감소에서 통계적으로 유의미한 차이를 보였습니다(p=0.010 및 p=0.00005). TNX-102 SL은 최소한의 부작용으로 양호한 내약성을 나타냈으며, 주로 투여 부위에서 임시적인 혀의 마비로 구성되었습니다.
Tonix Pharmaceuticals (TNXP) a annoncé que la FDA a fixé une date d'objectif PDUFA au 15 août 2025 pour la décision d'approbation de commercialisation de leur TNX-102 SL pour le traitement de la fibromyalgie. Ce médicament, qui a obtenu la désignation Fast Track en juillet 2024, est un analgésique non opioïde à action centrale qui pourrait devenir le premier nouveau traitement de la fibromyalgie en plus de 15 ans.
La soumission de l'NDA est soutenue par deux essais de phase 3 réussis : RELIEF (terminé en décembre 2020) et RESILIENT (terminé en décembre 2023), montrant tous deux une réduction statistiquement significative de la douleur par rapport au placebo (p=0.010 et p=0.00005 respectivement). TNX-102 SL a démontré une bonne tolérance avec des événements indésirables minimaux, consistant principalement en un engourdissement temporaire de la langue au site d'administration.
Tonix Pharmaceuticals (TNXP) gab bekannt, dass die FDA ein PDUFA-Zieldatum für den 15. August 2025 für die Entscheidung über die Marktzulassung ihres TNX-102 SL zur Behandlung von Fibromyalgie festgelegt hat. Das Medikament, das im Juli 2024 die Fast Track-Einstufung erhielt, ist ein nicht-opioides, zentral wirksames Analgetikum, das die erste neue Behandlung für Fibromyalgie seit über 15 Jahren werden könnte.
Der NDA-Antrag wird von zwei erfolgreichen Phase-3-Studien unterstützt: RELIEF (abgeschlossen im Dezember 2020) und RESILIENT (abgeschlossen im Dezember 2023), die beide eine statistisch signifikante Schmerzlinderung im Vergleich zu Placebo zeigten (p=0.010 und p=0.00005). TNX-102 SL zeigte eine günstige Verträglichkeit mit minimalen unerwünschten Ereignissen, die hauptsächlich aus vorübergehender Taubheit der Zunge an der Injektionsstelle bestanden.
- Fast Track designation granted by FDA, potentially expediting review process
- Two successful Phase 3 trials with statistically significant results
- Large market potential with over 10 million adults affected in the U.S.
- Could be first new fibromyalgia treatment in 15+ years
- Favorable safety profile with minimal adverse events
- FDA final decision still pending until August 2025
- to treating only one condition (fibromyalgia) currently
Insights
The FDA's PDUFA date assignment for TNX-102 SL represents a crucial milestone in addressing the significant unmet need in fibromyalgia treatment. The drug's potential as the first new treatment in 15+ years is particularly noteworthy given the robust efficacy data from two Phase 3 trials. The p-values of
The safety profile is particularly compelling - adverse events below
For Tonix Pharmaceuticals, with a market cap of
The August 2025 PDUFA date provides a clear timeline for potential value creation. Given the strong Phase 3 data and established safety profile, the probability of approval appears favorable, though regulatory risks remain. Investors should monitor the review process closely, as positive developments could significantly impact the company's valuation, particularly given its current modest market cap relative to the market opportunity.
Tonix received FDA’s Day 74 Letter granting TNX-102 SL a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025
TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA
Fibromyalgia affects more than 10 million adults in the U.S., who are mostly women
TNX-102 SL has the potential to be the first member of a new class of analgesic drugs for fibromyalgia and first new drug for its treatment in more than 15 years
NDA based on two statistically significant Phase 3 studies of TNX-102 SL for the management of fibromyalgia, in which TNX-102 SL was generally well tolerated
CHATHAM, N.J., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company) today announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing approval for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia. TNX-102 SL is a non-opioid, centrally-acting analgesic. Fibromyalgia is a common chronic pain condition that affects mostly women.
“We look forward to working closely with the FDA throughout the review period in advance of the August 15, 2025, PDUFA goal date,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe that TNX-102 SL has the potential to be the first member of a new class of medicines for the management of fibromyalgia, a debilitating condition affecting over 10 million adults in the U.S. Data from our pivotal Phase 3 trials support that TNX-102 SL can provide fibromyalgia patients with significant reduction in pain with favorable tolerability, helping to address the significant unmet need in this community.”
Dr. Lederman continued, “TNX-102 SL was previously granted Fast Track designation for fibromyalgia by the FDA in July of 2024. Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need. This recognition from FDA confirms that the Agency recognizes the significant unmet needs of the fibromyalgia community, who have been waiting for a new drug for over 15 years.”
The accepted NDA is supported by data from 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. The first Phase 3 trial, RELIEF, of TNX-102 SL 5.6 mg in fibromyalgia, completed in December 2020, met its pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p=0.010). In the confirmatory Phase 3 RESILIENT study in fibromyalgia, completed in December 2023, TNX-102 SL again met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p =0.00005). 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. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study). Excluding COVID-19, rates of systemic adverse events in each of the two studies were all below
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. 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.
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. The FDA has accepted the NDA filing for TNX-102 SL for fibromyalgia and assigned a PDUFA goal date of August 15, 2025. 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. In July 2024, Tonix announced 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.
Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182
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ICR Healthcare
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(443) 213-0505
Media Contact
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Putnam Insights
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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 back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw or stomach
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- breaking out in a cold sweat
- nausea or vomiting
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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 problems
- narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
- uncontrolled high blood pressure
- hemiplegic 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 circulation
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- taken 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 toes
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- increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
- medication 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 throat
- seizures 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.
FAQ
When is the PDUFA date for Tonix's TNX-102 SL (TNXP) fibromyalgia treatment?
What were the Phase 3 trial results for TNXP's TNX-102 SL in fibromyalgia?
What is the market size for TNXP's fibromyalgia treatment TNX-102 SL?
What are the main side effects of TNXP's TNX-102 SL?
When did TNXP receive Fast Track designation for TNX-102 SL?
