Tonix Pharmaceuticals Announces Potential Positive Impact of the U.S. National Academies (NASEM) New Definition of Long COVID on the Size of the Fibromyalgia Market for Tonmya™
Tonix Pharmaceuticals (TNXP) reports potential positive impact on the fibromyalgia market for Tonmya™ due to the new definition of Long COVID by the U.S. National Academies (NASEM). Key points:
1. Fibromyalgia is now recognized as a 'diagnosable condition' in Long COVID patients.
2. This may expand the addressable market for Tonmya beyond pre-pandemic estimates.
3. Tonmya, a non-opioid analgesic for fibromyalgia, has Fast Track designation.
4. NDA submission target: second half of 2024, potential FDA approval in 2025.
5. Estimated 14 million U.S. adults suffer from Long COVID, with over 40% potentially presenting fibromyalgia-like symptoms.
Tonix Pharmaceuticals (TNXP) riporta un potenziale impatto positivo sul mercato della fibromialgia per Tonmya™ a causa della nuova definizione di Long COVID da parte delle Accademie Nazionali degli Stati Uniti (NASEM). Punti chiave:
1. La fibromialgia è ora riconosciuta come una 'condizione diagnosticabile' nei pazienti con Long COVID.
2. Questo potrebbe espandere il mercato trattabile per Tonmya oltre le stime pre-pandemia.
3. Tonmya, un analgesico non oppioide per la fibromialgia, ha ottenuto la designazione Fast Track.
4. Obiettivo di sottomissione NDA: seconda metà del 2024, potenziale approvazione FDA nel 2025.
5. Si stima che 14 milioni di adulti negli Stati Uniti soffrano di Long COVID, con oltre il 40% che potrebbe presentare sintomi simili alla fibromialgia.
Tonix Pharmaceuticals (TNXP) informa sobre un potencial impacto positivo en el mercado de la fibromialgia para Tonmya™ debido a la nueva definición de Long COVID por parte de las Academias Nacionales de EE. UU. (NASEM). Puntos clave:
1. La fibromialgia ahora se reconoce como una 'condición diagnosticable' en pacientes con Long COVID.
2. Esto podría expandir el mercado accesible para Tonmya más allá de las estimaciones previas a la pandemia.
3. Tonmya, un analgésico no opioide para la fibromialgia, tiene designación de Vía Rápida.
4. Objetivo de presentación de NDA: segunda mitad de 2024, posible aprobación de la FDA en 2025.
5. Se estima que 14 millones de adultos en EE. UU. sufren de Long COVID, con más del 40% presentando potencialmente síntomas similares a la fibromialgia.
Tonix Pharmaceuticals (TNXP)는 미국 국립 아카데미(NASEM)의 Long COVID에 대한 새로운 정의로 인해 Tonmya™의 섬유근육통 시장에 긍정적인 영향을 미칠 가능성을 보고했습니다. 주요 요점:
1. 섬유근육통은 이제 Long COVID 환자의 '진단 가능한 상태'로 인정받습니다.
2. 이는 Tonmya의 대상 시장을 팬데믹 이전의 추정치를 넘어 확대할 수 있습니다.
3. Tonmya는 섬유근육통을 위한 비오피오이드 진통제이며 패스트 트랙 지정을 받았습니다.
4. NDA 제출 목표: 2024년 하반기, 2025년 FDA 승인 가능성.
5. 약 1,400만 명의 미국 성인이 Long COVID로 고통받고 있으며, 그 중 40% 이상이 섬유근육통 유사 증상을 나타낼 가능성이 있습니다.
Tonix Pharmaceuticals (TNXP) signale un impact potentiel positif sur le marché de la fibromyalgie pour Tonmya™ en raison de la nouvelle définition du Long COVID par les Académies nationales des États-Unis (NASEM). Points clés :
1. La fibromyalgie est désormais reconnue comme une 'condition diagnosticable' chez les patients atteints de Long COVID.
2. Cela pourrait étendre le marché adressable pour Tonmya au-delà des estimations d'avant la pandémie.
3. Tonmya, un analgésique non opioïde pour la fibromyalgie, a obtenu la désignation Fast Track.
4. Objectif de soumission de NDA : deuxième moitié de 2024, approbation potentielle par la FDA en 2025.
5. On estime que 14 millions d'adultes américains souffrent de Long COVID, dont plus de 40 % pourraient présenter des symptômes semblables à la fibromyalgie.
Tonix Pharmaceuticals (TNXP) berichtet über einen möglichen positiven Einfluss auf den Fibromyalgie-Markt für Tonmya™, bedingt durch die neue Definition von Long COVID durch die nationalen Akademien der USA (NASEM). Wichtige Punkte:
1. Fibromyalgie wird jetzt als 'diagnostizierbare Erkrankung' bei Long COVID-Patienten anerkannt.
2. Dies könnte den adressierbaren Markt für Tonmya über die Schätzungen vor der Pandemie hinaus erweitern.
3. Tonmya, ein nicht-opioid Schmerzmittel für Fibromyalgie, hat die Fast Track-Bezeichnung erhalten.
4. Ziel für die NDA-Einreichung: Zweite Hälfte 2024, potenzielle FDA-Zulassung im Jahr 2025.
5. Geschätzt 14 Millionen US-Erwachsene leiden an Long COVID, wobei über 40% möglicherweise Symptome zeigen, die Fibromyalgie ähneln.
- Potential expansion of addressable market for Tonmya due to new Long COVID definition
- Fast Track designation for Tonmya, a non-opioid analgesic for fibromyalgia
- NDA submission target set for second half of 2024, with potential FDA approval in 2025
- Completed proof-of-concept study in Long COVID patients showed nominal benefit in fatigue with TNX-102 SL treatment
- None.
Insights
The NASEM's new definition of Long COVID, which includes fibromyalgia as a "diagnosable condition", could significantly impact the market potential for Tonix Pharmaceuticals' Tonmya. This development is particularly noteworthy for several reasons:
- Expanded Market: With an estimated 14 million U.S. adults suffering from Long COVID, the potential patient pool for Tonmya could increase substantially. If the company's estimate that
40% of Long COVID patients present symptoms overlapping with fibromyalgia is accurate, this could translate to approximately 5.6 million additional potential patients. - Timing: Tonix's planned NDA submission in the second half of 2024 aligns well with this new definition, potentially allowing the company to capitalize on the expanded market if approved in 2025.
- Clinical Relevance: The company's proof-of-concept study in Long COVID patients showing a nominal benefit in fatigue with TNX-102 SL treatment supports the potential efficacy in this expanded patient population.
However, it's important to note that while this development is promising, several factors remain uncertain:
- The exact proportion of Long COVID patients who will meet the diagnostic criteria for fibromyalgia is still unknown.
- The effectiveness of Tonmya in this specific patient population needs further validation.
- Regulatory approval is still pending and the FDA's stance on this expanded indication is yet to be determined.
Investors should closely monitor the progress of Tonix's NDA submission and any subsequent communications with the FDA regarding the potential inclusion of Long COVID-related fibromyalgia in Tonmya's indication.
The potential expansion of the fibromyalgia market due to Long COVID presents a significant opportunity for Tonix Pharmaceuticals. Here's a breakdown of the financial implications:
- Market Size: Pre-pandemic estimates put the fibromyalgia market at 10 million adults in the U.S. The addition of Long COVID patients could potentially more than double this market.
- Revenue Potential: Assuming Tonmya gains approval and captures even a modest market share, the revenue implications could be substantial. For context, current fibromyalgia treatments can generate annual sales in the hundreds of millions to billions of dollars.
- Competitive Advantage: Being one of the first to target this expanded market could give Tonix a first-mover advantage, potentially leading to higher market share and brand recognition.
- R&D Efficiency: The company's existing research on Tonmya for fibromyalgia can be leveraged for this expanded indication, potentially reducing additional R&D costs.
However, investors should consider these risk factors:
- Regulatory Hurdles: FDA approval is not guaranteed and the process may require additional studies or data.
- Competition: Other pharmaceutical companies may also target this expanded market, potentially leading to increased competition and pricing pressure.
- Market Penetration: The actual uptake of Tonmya in this new patient population remains uncertain and will depend on factors such as efficacy, safety profile and pricing.
While the potential market expansion is promising, it's important for investors to closely monitor Tonix's progress in the regulatory process and any updates on clinical efficacy in Long COVID patients before making investment decisions.
Fibromyalgia is a “diagnosable condition” in people suffering from Long COVID according to NASEM1
Diagnosing fibromyalgia in Long COVID patients is expected to expand the potential addressable market for Tonmya relative to pre-COVID-19 pandemic estimates2
Tonmya is a potential new first-line non-opioid analgesic under development for the management of fibromyalgia with Fast Track designation: NDA submission target is second half of 2024, with potential for FDA approval in 2025
CHATHAM, N.J., July 31, 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 provided an update on the potential impact on the size of the fibromyalgia market for its development candidate Tonmya (TNX-102 SL or cyclobenzaprine HCl sublingual tablets), based on the new definition of Long COVID by the U.S. National Academies of Sciences, Engineering and Medicine (NASEM) announced on June 11, 20241.
“The consensus report from the NASEM concludes that fibromyalgia is a ‘diagnosable condition’ in people suffering from Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “It has long been recognized that fibromyalgia can arise after a viral illness and is considered an infection-associated chronic condition.2,3 The NASEM definition confirms that fibromyalgia occurs after infection with the SARS-CoV-2 virus in some patients with Long COVID. Tonix is planning to file a New Drug Application (NDA) for Tonmya in the second half of this year for the indication of fibromyalgia with the U.S. Food and Drug Administration (FDA). We believe that diagnosing fibromyalgia in Long COVID patients will increase the potential market for Tonmya following approval as compared to market estimates from before the COVID-19 pandemic.”
Dr. Lederman continued, “Prior to the COVID-19 pandemic, the prevalence of fibromyalgia was estimated to be more than 10 million adults in the U.S.4 The U.S. Census Bureau, the National Center for Health Statistics Household Pulse Survey and the Centers for Disease Control and Prevention (CDC) estimate that approximately
About Fibromyalgia
Fibromyalgia is a 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.
About Tonmya* (also known as TNX-102 SL)
Tonmya™ (cyclobenzaprine HCl sublingual tablets) is a centrally acting, non-opioid, non-addictive, investigational drug being developed as a daily bedtime medication for the management of fibromyalgia, alcohol use disorder and agitation in Alzheimer’s disease. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride TNX-102 SL provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035. 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. 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 recently announced receipt of the formal minutes from both recent pre-New Drug Application (NDA) meetings with the U.S. Food and Drug Administration (FDA) for Tonmya for the management of fibromyalgia. At these meetings, the Company and the FDA agreed on the proposed content and timing of an NDA submission. The Company reaffirmed its guidance to submit the NDA for Tonmya to the FDA in the second half of 2024 which would allow for a potential FDA approval in 2025. Tonmya for the management of fibromyalgia has been granted FDA Fast Track designation.
About the Phase 2 PREVAIL Study
The Phase 2 PREVAIL study was a 14-week double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-102 SL taken daily at bedtime in patients with multi-site pain associated with Long COVID. The trial was conducted at approximately 30 sites in the U.S. The study was not significant on the primary efficacy endpoint of the change from baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. Nominal activity of TNX-102 SL was shown in fatigue.
For more information, see ClinicalTrials.gov Identifier: NCT05472090.
About Long COVID
Long COVID is an infection-associated chronic condition (IACC) that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems. Long COVID is the term widely recognized for the post-COVID syndrome formerly known as Post-acute sequelae of COVID-19, or PASC. Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develops Long COVID. These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems.
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.
1U.S. National Academies of Sciences, Engineering, and Medicine. 2024. A Long COVID Definition: A chronic, systemic disease state with profound consequences. Washington, DC: The National Academies Press. https://doi.org/10.17226/27768. http://www.nationalacademies.org/long-covid-definition.
2Clauw DJ, et al. Pain. 2020 161(8):1694–7.
3Choutka J, et al. Nat Med. 2022 28(5):911–23.
4Vincent A, et al. Arthritis Care Res (Hoboken). 2013 65(5):786-92. doi: 10.1002
5National Center for Health Statistics. U.S. Census Bureau, Household Pulse Survey, 2022–2024. Long COVID. Generated interactively: July 22, 2024 from https://www.cdc.gov/nchs/covid19/pulse/long-covid.htm
6Gavrilova, N, et al. 2022. Pathophysiology 29(1):24-29. https://doi.org/10.3390/ pathophysiology29010003.
7Clauw, DJ, and L Calabrese. 2024. Annals of the Rheumatic Diseases 83:136-138
8Savin, E., et al. 2023. PLoS One 18(2):e0281593. https://doi.org/10.1371/journal. pone.0281593.
9Thaweethai T, et al. JAMA. 2023 329(22):1934-1946.
10Feb 22, 2023 Tonix Pharmaceuticals Press Release. URL: https://ir.tonixpharma.com/news-events/press-releases/detail/1369/tonix-pharmaceuticals-describes-emerging-research-on-the
11September 21, 2022, Tonix Pharmaceuticals Poster at the IASP, “Retrospective observational database study of patients with Long COVID with multi-site pain, fatigue and insomnia”. URL: www.tonixpharma.com/wp-content/uploads/2022/09/Retrospective-Observational-Database-Study-of-Patients-with-Long-COVID-with-Multi-Site-Pain-Fatigue-and-Insomnia_A-Real-World-Analysis-of-Symptomatology-and-Opioid-Use.pdf
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
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Tonix Pharmaceuticals
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FAQ
What is the potential impact of the new Long COVID definition on Tonix Pharmaceuticals' Tonmya (TNXP)?
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What is the estimated prevalence of Long COVID in the U.S. according to the press release?
What percentage of Long COVID patients may present with fibromyalgia-like symptoms according to Tonix Pharmaceuticals' (TNXP) analysis?
