Tonix’s Experimental Non-Opioid Analgesic Treatment for Fibromyalgia Could Start Bringing Relief Later This Year
Tonix Pharmaceuticals (NASDAQ:TNXP) is advancing TNX-102 SL, a non-opioid treatment for fibromyalgia, with potential FDA approval by August 15, 2025. The sublingual medication, taken at bedtime, targets sleep disturbance in fibromyalgia patients, addressing a critical market need where 85% of patients fail first-line therapy.
The chronic pain drug market, including fibromyalgia, is projected to grow from $72.10 billion in 2024 to $115.51 billion by 2031. TNX-102 SL could serve both traditional fibromyalgia patients and Long COVID sufferers, as fibromyalgia has been recognized as a diagnosable condition in Long COVID by the National Academies of Science, Engineering and Medicine. According to recent data, approximately 17.8 million U.S. adults have long COVID.
Tonix Pharmaceuticals (NASDAQ:TNXP) sta sviluppando TNX-102 SL, un trattamento non oppioide per la fibromialgia, con una potenziale approvazione da parte della FDA entro il 15 agosto 2025. Il farmaco sublinguale, da assumere prima di coricarsi, mira a migliorare i disturbi del sonno nei pazienti affetti da fibromialgia, rispondendo a un bisogno critico del mercato, dato che l'85% dei pazienti non riesce a ottenere risultati con le terapie di prima linea.
Il mercato dei farmaci per il dolore cronico, inclusa la fibromialgia, è previsto crescere da 72,10 miliardi di dollari nel 2024 a 115,51 miliardi di dollari entro il 2031. TNX-102 SL potrebbe essere utile sia per i pazienti tradizionali affetti da fibromialgia che per coloro che soffrono di Long COVID, poiché la fibromialgia è stata riconosciuta come condizione diagnosticabile nel Long COVID dalle Accademie Nazionali delle Scienze, dell'Ingegneria e della Medicina. Secondo dati recenti, circa 17,8 milioni di adulti negli Stati Uniti soffrono di Long COVID.
Tonix Pharmaceuticals (NASDAQ:TNXP) está avanzando con TNX-102 SL, un tratamiento no opioide para la fibromialgia, con una posible aprobación de la FDA para el 15 de agosto de 2025. Este medicamento sublingual, que se toma antes de dormir, se dirige a los trastornos del sueño en pacientes con fibromialgia, abordando una necesidad crítica del mercado donde el 85% de los pacientes no responde a la terapia de primera línea.
Se proyecta que el mercado de medicamentos para el dolor crónico, incluida la fibromialgia, crezca de 72,10 mil millones de dólares en 2024 a 115,51 mil millones de dólares para 2031. TNX-102 SL podría servir tanto a pacientes tradicionales de fibromialgia como a aquellos que sufren de Long COVID, ya que la fibromialgia ha sido reconocida como una condición diagnosticable en Long COVID por las Academias Nacionales de Ciencias, Ingeniería y Medicina. Según datos recientes, aproximadamente 17,8 millones de adultos en EE. UU. tienen Long COVID.
톤익스 제약 (NASDAQ:TNXP)는 섬유근육통에 대한 비오피오이드 치료제인 TNX-102 SL을 개발하고 있으며, 2025년 8월 15일까지 FDA 승인을 받을 가능성이 있습니다. 취침 전에 복용하는 이 설하 약물은 섬유근육통 환자들의 수면 장애를 목표로 하여, 1차 치료에 실패한 85%의 환자들이 있는 시장의 중요한 필요를 해결합니다.
섬유근육통을 포함한 만성 통증 약물 시장은 2024년 721억 달러에서 2031년까지 1155억 달러로 성장할 것으로 예상됩니다. TNX-102 SL은 전통적인 섬유근육통 환자와 롱 COVID 환자 모두에게 도움이 될 수 있으며, 섬유근육통은 롱 COVID에서 진단 가능한 상태로 인정받았습니다. 최근 데이터에 따르면, 미국에서 약 1780만 명의 성인이 롱 COVID를 앓고 있습니다.
Tonix Pharmaceuticals (NASDAQ:TNXP) fait progresser TNX-102 SL, un traitement non opioïde pour la fibromyalgie, avec une approbation potentielle de la FDA d'ici le 15 août 2025. Ce médicament sublingual, pris au coucher, cible les troubles du sommeil chez les patients atteints de fibromyalgie, répondant à un besoin critique du marché où 85 % des patients échouent aux thérapies de première ligne.
Le marché des médicaments contre la douleur chronique, y compris la fibromyalgie, devrait passer de 72,10 milliards de dollars en 2024 à 115,51 milliards de dollars d'ici 2031. TNX-102 SL pourrait servir à la fois aux patients traditionnels atteints de fibromyalgie et aux personnes souffrant de Long COVID, car la fibromyalgie a été reconnue comme une condition diagnostiquable dans le Long COVID par les Académies nationales des sciences, de l'ingénierie et de la médecine. Selon des données récentes, environ 17,8 millions d'adultes aux États-Unis souffrent de Long COVID.
Tonix Pharmaceuticals (NASDAQ:TNXP) entwickelt TNX-102 SL, eine nicht-opioide Behandlung für Fibromyalgie, mit einer möglichen Genehmigung durch die FDA bis zum 15. August 2025. Das sublinguale Medikament, das vor dem Schlafengehen eingenommen wird, zielt auf Schlafstörungen bei Fibromyalgie-Patienten ab und spricht ein kritisches Marktbedürfnis an, da 85 % der Patienten mit der Erstlinientherapie nicht erfolgreich sind.
Der Markt für chronische Schmerzmittel, einschließlich Fibromyalgie, wird voraussichtlich von 72,10 Milliarden US-Dollar im Jahr 2024 auf 115,51 Milliarden US-Dollar bis 2031 wachsen. TNX-102 SL könnte sowohl traditionellen Fibromyalgie-Patienten als auch Long-COVID-Betroffenen dienen, da Fibromyalgie von den Nationalen Akademien der Wissenschaften, Ingenieurwesen und Medizin als diagnostizierbare Erkrankung bei Long COVID anerkannt wurde. Laut aktuellen Daten leiden etwa 17,8 Millionen Erwachsene in den USA an Long COVID.
- Potential FDA approval for TNX-102 SL by August 15, 2025
- Large market opportunity in both fibromyalgia and Long COVID patients
- Addresses high unmet need with 85% of patients failing first-line therapy
- Chronic pain market projected to grow to $115.51 billion by 2031
- Encouraging results in pilot study for Long COVID-related multi-site pain
- Product not yet approved by FDA
- Will face competition from established treatments like Lyrica and Cymbalta
- Investigational drug with no guaranteed market success
Insights
Tonix Pharmaceuticals (NASDAQ: TNXP) has reached a critical regulatory milestone with TNX-102 SL, its non-opioid treatment for fibromyalgia now under FDA review with a decision expected by August 15, 2025. If approved, this sublingual formulation would offer an alternative mechanism of action by targeting sleep disturbances that exacerbate fibromyalgia pain, differentiating it from existing treatments like gabapentinoids and SNRIs.
The timing is strategically significant as the non-opioid pain management sector gains momentum, evidenced by Vertex's recent FDA approval for Journavx (suzetrigine). The addressable market for TNX-102 SL appears substantial, with the chronic pain market projected to grow from
What's particularly noteworthy is the potential expanded application to Long COVID patients with fibromyalgia symptoms. With approximately
While this sponsored content naturally presents an optimistic outlook, the concrete FDA review timeline and completed pilot study in Long COVID patients represent tangible progress toward commercialization in a market where
CHATHAM, NEW JERSEY / ACCESS Newswire / March 31, 2025 / This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.
Pain management is getting an upgrade, and Wall Street seems to be taking notice. For decades the pain drug market has been dominated by opioids that cause adverse side effects like addiction and overdose. In the wake of the opioid crisis and the new limitations on prescribing them, scientists and companies are chasing novel approaches to acute and chronic pain. A new crop of drugs is coming to the market to address acute and potentially chronic pain without many of the side effects, and that has Wall Street and pain sufferers paying close attention.
Vertex Sets the Stage
One only has to look at Vertex Pharmaceuticals, the drug company pursuing acute pain with a first-in-class NaV1.8 pain signal inhibitor drug. In January Vertex won Food and Drug Administration approval for VX-548, Journavx® (suzetrigine) its non-opioid drug for acute pain Suzetrigine. The company now sports a market capitalization of
Another company going after the pain market - albeit in a different area - with a non-opiate pain remedy for fibromyalgia is Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP). Fibromyalgia is a chronic pain condition, not an acute pain condition. Fibromyalgia arises because of abnormal pain signaling in the brain, unlike acute pain, which is caused by tissue and nerve damage. The fully integrated biopharmaceutical company is developing its first-in-class tertiary amine tricyclic drug that acts in the central nervous system. Their drug TNX-102 SL* (cyclobenzaprine HCl sublingual tablets), a non-opioid investigational drug targeting fibromyalgia, which affects millions of Americans, mostly women.
This type of pain impacts a large portion of the body or can be specific to extremities like the feet or hands. Fibromyalgia inflicts pain over many parts of the body, which is called "widespread" or "multi-site" pain. In addition to living with the chronic widespread pain of fibromyalgia patients often complain of fatigue and sleep problems. Two other types of drugs are already approved to treat fibromyalgia, gabapentinoids like Pfizer's Lyrica® and SNRIs like Lilly's Cymbalta®. Despite the availability of these once-popular brands, many fibromyalgia patients are dissatisfied. Unlike acute pain, most experts agree that opioids should never be used to treat fibromyalgia. Most experts agree that opioids provide no meaningful benefit to fibromyalgia patients and only lead to addiction.
Tonix Positioning to Lead
Like Vertex in the acute pain market, Tonix is hard at work positioning itself to become a leader in treating the chronic pain of fibromyalgia with a non-addictive treatment that's in the final stages of seeking FDA approval.
It makes sense Tonix is going after the fibromyalgia market. Because fibromyalgia patients are typically affected for years or decades, and TNX-102 SL is expected to be used daily at bedtime, the number of prescriptions for each patient is expected to be larger than for acute pain which is typically a two-week course. However, both markets are large. According to one estimate the chronic pain drug market, which includes fibromyalgia, is forecast to grow from
Sleep disturbance can have a big impact on chronic pain, making it feel worse. Lack of sleep can also hyperexcite the central nervous system (CNS), lowering pain tolerance. TNX-102 SL is a sublingual formulation that is designed to be taken daily at bedtime and to target the disturbed sleep of fibromyalgia. TNX-102 SL is not believed to be a sedative or hypnotic like Ambien® or Lunesta®. These traditional sedatives fail to address the sleep problem of fibromyalgia. Ambien has been studied and it does not improve fibromyalgia symptoms.
FDA Approval Could Come as Soon as August
TNX 102-SL is currently being evaluated by the FDA and the company expects the FDA could issue a decision on marketing authorization on August 15, 2025. That means it could potentially be on the market in 2025, giving fibromyalgia sufferers a much-needed new option. As it stands, Tonix says
Fibromyalgia can occur by itself, but it can also occur in the context of other conditions. The National Academies of Science, Engineering and Medicine (NASEM) recognized in June of last year that fibromyalgia is a diagnosable condition in Long COVID. The National Institute of Health just recently recognized that targeting sleep quality is a promising approach to treating long COVID. Tonix has completed a pilot study in multi-site pain associated with Long COVID and got encouraging results, particularly on improving fatigue.
The recommendation by the NASEM to diagnose fibromyalgia in appropriate Long COVID patients may expand Tonix's addressable market. After all, the number of long COVID sufferers, which according to the World Health Organization is about 6 in every 100 people who contract COVID, outnumbers those who are believed to suffer from fibromyalgia without Long COVID. New data from the Medical Expenditure Panel Survey support prior findings that around
From fibromyalgia to Long COVID patients and Wall Street, many are looking with hope at a new class of drugs to address an unmet need: pain medication that is not addictive and still effective. Companies like Vertex on the acute pain side and Tonix targeting fibromyalgia on the chronic pain side, are aiming to be leaders in these burgeoning markets. With Tonix's treatment under FDA review, it could be only a matter of time before that can potentially become a reality.
*TNX-102 SL is an investigational new medicine and has not been approved for any indication.
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This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice.
Featured photo by Keenan Constance on Unsplashed.
Contact Information
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
862.904.8182
SOURCE: Tonix Pharmaceuticals Holding
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FAQ
When is the expected FDA approval date for Tonix's TNX-102 SL fibromyalgia treatment (TNXP)?
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How does Tonix's TNX-102 SL (TNXP) differ from current fibromyalgia treatments?
What percentage of fibromyalgia patients could benefit from TNXP's new treatment?
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