Tonix Pharmaceuticals Granted Fast Track Designation by FDA for Tonmya™ for Fibromyalgia
Tonix Pharmaceuticals (Nasdaq: TNXP) has received Fast Track designation from the FDA for Tonmya™, its non-opioid analgesic drug for fibromyalgia. This designation recognizes fibromyalgia as a serious condition affecting over 10 million U.S. adults and aims to expedite FDA review. Tonix plans to submit a New Drug Application (NDA) in the second half of 2024, with potential market entry in 2025. If approved, Tonmya could be the first new fibromyalgia drug in over 15 years. The company is positioning Tonmya as a first-line, long-term daily treatment option. Fast Track status allows for more frequent FDA interactions and the possibility of Priority Review, potentially accelerating the approval process.
Tonix Pharmaceuticals (Nasdaq: TNXP) ha ricevuto la designazione Fast Track dalla FDA per Tonmya™, il suo farmaco analgesico non oppioide per la fibromialgia. Questa designazione riconosce la fibromialgia come una condizione seria che colpisce oltre 10 milioni di adulti negli Stati Uniti e ha l'obiettivo di accelerare la revisione da parte della FDA. Tonix prevede di presentare una Nuova Domanda di Autorizzazione all'Immissione in Commercio (NDA) nella seconda metà del 2024, con un possibile ingresso nel mercato nel 2025. Se approvato, Tonmya potrebbe essere il primo nuovo farmaco per la fibromialgia in oltre 15 anni. L'azienda sta posizionando Tonmya come un'opzione di trattamento quotidiano a lungo termine di prima linea. Lo status di Fast Track consente interazioni più frequenti con la FDA e la possibilità di una Revisione Prioritaria, accelerando potenzialmente il processo di approvazione.
Tonix Pharmaceuticals (Nasdaq: TNXP) ha recibido la designación Fast Track de la FDA para Tonmya™, su medicamento analgésico no opioide para la fibromialgia. Esta designación reconoce la fibromialgia como una condición grave que afecta a más de 10 millones de adultos en los EE. UU. y tiene como objetivo acelerar la revisión por parte de la FDA. Tonix planea presentar una Nueva Solicitud de Medicamento (NDA) en la segunda mitad de 2024, con una posible entrada al mercado en 2025. Si se aprueba, Tonmya podría ser el primer nuevo medicamento para la fibromialgia en más de 15 años. La empresa está posicionando a Tonmya como una opción de tratamiento diario a largo plazo de primera línea. El estado de Fast Track permite interacciones más frecuentes con la FDA y la posibilidad de Revisión Prioritaria, lo que podría acelerar el proceso de aprobación.
톤익스 제약사(Nasdaq: TNXP)는 FDA로부터 섬유근육통을 위한 비오피오이드 진통제인 톤미아™에 대해 패스트 트랙 지정을 받았습니다. 이 지명은 섬유근육통이 1천만 명 이상의 미국 성인에게 영향을 미치는 중대한 질환임을 인정하며, FDA의 심사를 가속화하는 것을 목표로 합니다. 톤익스는 2024년 하반기에 신약신청서(NDA)를 제출할 계획이며, 2025년에 시장에 진입할 가능성이 있습니다. 승인이 된다면 톤미아는 15년 이상 만에 처음으로 선보이는 섬유근육통 치료제가 될 수 있습니다. 이 회사는 톤미아를 1차계열 장기 일일 치료 옵션으로 포지셔닝하고 있습니다. 패스트 트랙 상태는 FDA와의 더 빈번한 상호작용과 우선 심사 가능성을 허용하여 승인 과정을 가속화할 수 있습니다.
Tonix Pharmaceuticals (Nasdaq: TNXP) a reçu la désignation Fast Track de la FDA pour Tonmya™, son médicament analgésique non opioïde pour la fibromyalgie. Cette désignation reconnaît la fibromyalgie comme une condition grave touchant plus de 10 millions d'adultes aux États-Unis et vise à accélérer l'examen par la FDA. Tonix prévoit de soumettre une Demande de Nouveau Médicament (NDA) dans la deuxième moitié de 2024, avec une entrée potentielle sur le marché en 2025. Si approuvé, Tonmya pourrait être le premier nouveau médicament pour la fibromyalgie en plus de 15 ans. L'entreprise positionne Tonmya comme une option de traitement quotidien de première intention à long terme. Le statut Fast Track permet des interactions plus fréquentes avec la FDA et la possibilité d'une Revue Prioritaire, ce qui pourrait accélérer le processus d'approbation.
Die Tonix Pharmaceuticals (Nasdaq: TNXP) hat von der FDA die Fast Track-Status für Tonmya™, ihr nicht-opioides Schmerzmittel zur Behandlung von Fibromyalgie, erhalten. Diese Auszeichnung erkennt Fibromyalgie als schwerwiegende Erkrankung an, die mehr als 10 Millionen Erwachsene in den USA betrifft, und zielt darauf ab, die Überprüfung durch die FDA zu beschleunigen. Tonix plant, im zweiten Halbjahr 2024 einen neuen Arzneimittelantrag (NDA) einzureichen, mit einer möglichen Markteinführung im Jahr 2025. Sollte es genehmigt werden, könnte Tonmya das erste neue Medikament gegen Fibromyalgie seit über 15 Jahren sein. Das Unternehmen positioniert Tonmya als eine Erstlinientherapie für eine langfristige tägliche Behandlung. Der Fast Track-Status ermöglicht häufigere Interaktionen mit der FDA und die Möglichkeit eines Prioritätsreviews, was den Genehmigungsprozess potenziell beschleunigen kann.
- Fast Track designation granted by FDA for Tonmya, potentially expediting the review process
- NDA submission on track for second half of 2024, with potential market entry in 2025
- Tonmya could be the first new fibromyalgia drug in over 15 years
- Addressing a large market with over 10 million U.S. adults affected by fibromyalgia
- Potential for Priority Review, which could accelerate the approval process
- None.
Insights
The FDA's Fast Track designation for Tonmya (cyclobenzaprine HCl sublingual tablets) is a significant development for Tonix Pharmaceuticals and the fibromyalgia treatment landscape. This designation acknowledges fibromyalgia as a serious condition affecting over 10 million U.S. adults and recognizes the potential of Tonmya to address an unmet medical need.
Key points to consider:
- Tonmya could become the first new drug for fibromyalgia in over 15 years, potentially revolutionizing treatment options.
- The non-opioid, centrally-acting analgesic mechanism of Tonmya is noteworthy, given the ongoing opioid crisis and the need for safer pain management alternatives.
- The Fast Track designation may expedite the FDA review process, potentially bringing this treatment to market sooner than traditional pathways.
However, investors should note that while this news is promising, FDA approval is not guaranteed. The company still needs to submit its New Drug Application (NDA) in the second half of 2024 and the review process will follow. The market potential for Tonmya, if approved, could be substantial given the large patient population and current treatment options.
This Fast Track designation represents a positive development for Tonix Pharmaceuticals (NASDAQ: TNXP) from a financial perspective. Here's why:
- Potential for expedited market entry: If Tonmya receives FDA approval, it could reach the market faster, potentially leading to earlier revenue generation.
- Large addressable market: With over 10 million U.S. adults affected by fibromyalgia, the revenue potential is significant.
- Competitive advantage: Being the first new treatment in 15+ years could allow Tonix to capture a substantial market share.
- Reduced development costs: More frequent FDA interactions could lead to a more efficient development process, potentially reducing overall R&D expenses.
However, investors should consider:
- The company still needs to complete and submit its NDA in H2 2024.
- Even with Fast Track, there's no guarantee of FDA approval.
- The company's financial position and ability to fund the final stages of development and potential commercialization.
While this news is certainly positive, prudent investors should monitor the company's progress towards NDA submission and subsequent FDA decisions before making investment decisions.
Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need
Fast Track designation for Tonmya recognizes fibromyalgia as a serious condition impacting more than 10 million U.S. adults
NDA submission on track for second half 2024
Tonmya has the potential to be the first new drug for treating fibromyalgia in more than 15 years
CHATHAM, N.J., July 25, 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 U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. Tonmya is a non-opioid, centrally-acting analgesic drug under development for treating fibromyalgia, which is a common chronic pain condition affecting mostly women. The designation validates that fibromyalgia is a serious condition and that Tonmya has the potential to address this unmet medical need. Tonix previously announced alignment with the FDA regarding the content of its proposed NDA submission, following completion of the Company’s pre-NDA meetings. The Company reaffirms its guidance to submit the NDA for Tonmya to the FDA in the second half of 2024.
“The FDA’s decision to grant Tonmya Fast Track designation supports our goal of bringing this well tolerated, non-opioid analgesic treatment option to the market in 2025,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The designation underscores the importance of addressing the unmet needs of fibromyalgia patients, who report dissatisfaction with current treatment options. If approved by the FDA, we expect Tonmya to become the first new pharmacotherapy for fibromyalgia in over 15 years. The NDA being prepared supports Tonmya’s potential position as a first line therapy for fibromyalgia, indicated for long-term daily use at bedtime.”
The FDA’s Fast Track process is designed to facilitate development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs to potentially bring important new medicines to patients sooner. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development. Tonix plans to request Priority Review designation, and if granted, FDA may accelerate the review of the NDA. For more information on Fast Track designation, please visit the FDA’s website at www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
About Tonmya* (also known as TNX-102 SL)
Tonmya is a centrally acting, non-opioid, analgesic investigational drug for bedtime use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, the second pivotal Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all six key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function (all p≤0.001). RELIEF, the first statistically significant Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. 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). Tonix has announced the results of two positive pre-NDA meetings and alignment with FDA on nonclinical, clinical pharmacology, clinical and CMC features of the NDA submission.
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. Fibromyalgia afflicts an estimated 6 million to 12 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 anxiety and depression, headaches, and abdominal pain or cramps. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.
Tonix Pharmaceuticals Holding Corp.**
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
**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 Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182
Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505
Media Contact
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151
FAQ
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