Tonix's TNX 102-SL Could Offer New Hope of Pain Relief Without Narcotics for Fibromyalgia Sufferers
Tonix Pharmaceuticals (NASDAQ: TNXP) has submitted a new drug application (NDA) to the FDA for TNX-102 SL, a non-opioid treatment for fibromyalgia. The drug, which received Fast Track designation, targets sleep problems associated with fibromyalgia through a sublingual formulation of cyclobenzaprine hydrochloride.
In the recent RESILIENT phase 3 trial, TNX-102 SL demonstrated significant improvement in fibromyalgia pain (p-value=0.00005), sleep quality, fatigue, and overall symptoms. The global fibromyalgia market is projected to grow from $2.8 billion in 2024 to $4.13 billion in 2032. Currently, 85% of fibromyalgia patients fail first-line therapy, and 79% require multiple treatments.
FDA's decision on NDA acceptance is expected mid-December 2024, with potential approval by mid-August 2025.
Tonix Pharmaceuticals (NASDAQ: TNXP) ha presentato una nuova domanda di registrazione del farmaco (NDA) alla FDA per TNX-102 SL, un trattamento non oppioide per la fibromialgia. Il farmaco, che ha ricevuto la designazione Fast Track, affronta i problemi di sonno associati alla fibromialgia tramite una formulazione sublinguale di cloridrato di ciclobenzaprina.
Nell'ultimo studio clinico RESILIENT di fase 3, TNX-102 SL ha mostrato un miglioramento significativo nel dolore fibromialgico (p-value=0.00005), nella qualità del sonno, nella fatica e nei sintomi complessivi. Si prevede che il mercato globale della fibromialgia crescerà da 2,8 miliardi di dollari nel 2024 a 4,13 miliardi di dollari nel 2032. Attualmente, l'85% dei pazienti con fibromialgia non risponde alla terapia di prima linea e il 79% richiede più trattamenti.
La decisione della FDA sull'accettazione dell'NDA è attesa per metà dicembre 2024, con una possibile approvazione entro metà agosto 2025.
Tonix Pharmaceuticals (NASDAQ: TNXP) ha presentado una nueva solicitud de nuevo medicamento (NDA) a la FDA para TNX-102 SL, un tratamiento no opioide para la fibromialgia. El medicamento, que recibió la designación de Vía Rápida, aborda los problemas de sueño asociados con la fibromialgia mediante una formulación sublingual de clorhidrato de ciclobenzaprina.
En el reciente ensayo clínico de fase 3 RESILIENT, TNX-102 SL mostró una mejora significativa en el dolor de fibromialgia (p-valor=0.00005), la calidad del sueño, la fatiga y los síntomas generales. Se prevé que el mercado global de la fibromialgia crezca de 2.8 mil millones de dólares en 2024 a 4.13 mil millones de dólares en 2032. Actualmente, el 85% de los pacientes con fibromialgia no responden a la terapia de primera línea y el 79% requiere múltiples tratamientos.
Se espera que la decisión de la FDA sobre la aceptación de la NDA se emita a mediados de diciembre de 2024, con una posible aprobación para mediados de agosto de 2025.
톤익스 제약 (NASDAQ: TNXP)는 TNX-102 SL에 대한 새로운 의약품 신청(NDA)을 FDA에 제출했습니다. 이는 비마약성 치료제로, 섬유근육통과 관련된 수면 문제를 해결하기 위해 서브링구얼 형태의 클로르화 사이클로벤자프렌으로 제공됩니다. 이 약물은 패스트 트랙 지정을 받았습니다.
최근 RESILIENT 3상 시험에서 TNX-102 SL은 섬유근육통 통증(p-값=0.00005), 수면 질, 피로 및 전반적인 증상에서 크게 개선된 결과를 보였습니다. 글로벌 섬유근육통 시장은 2024년 28억 달러에서 2032년에는 41억 3천만 달러로 성장할 것으로 예상됩니다. 현재 85%의 섬유근육통 환자가 1차 치료에 실패하며, 79%는 여러 치료가 필요합니다.
NDA 수용에 대한 FDA의 결정은 2024년 12월 중순으로 예상되며, 2025년 8월 중순에는 승인이 이루어질 수 있습니다.
Tonix Pharmaceuticals (NASDAQ: TNXP) a soumis une nouvelle demande d'autorisation de mise sur le marché (NDA) à la FDA pour TNX-102 SL, un traitement non opioïde pour la fibromyalgie. Ce médicament, qui a reçu le statut Fast Track, cible les problèmes de sommeil associés à la fibromyalgie via une formulation sublinguale de chlorhydrate de cyclobenzaprine.
Dans le récent essai clinique de phase 3 RESILIENT, TNX-102 SL a démontré une amélioration significative des douleurs fibromyalgiques (p-valeur=0,00005), de la qualité du sommeil, de la fatigue et des symptômes globaux. Le marché mondial de la fibromyalgie devrait passer de 2,8 milliards de dollars en 2024 à 4,13 milliards de dollars en 2032. Actuellement, 85 % des patients fibromyalgiques échouent aux traitements de première ligne et 79 % nécessitent plusieurs traitements.
La décision de la FDA concernant l'acceptation de la NDA est attendue pour la mi-décembre 2024, avec une approbation potentielle d'ici la mi-août 2025.
Tonix Pharmaceuticals (NASDAQ: TNXP) hat einen neuen Zulassungsantrag (NDA) bei der FDA für TNX-102 SL eingereicht, eine nicht-opioide Behandlung für Fibromyalgie. Das Medikament, das den Status "Fast Track" erhalten hat, zielt auf Schlafprobleme im Zusammenhang mit Fibromyalgie durch eine sublinguale Formulierung von Cyclobenzaprin-Hydrochlorid ab.
Im kürzlich durchgeführten RESILIENT Phase 3-Test zeigte TNX-102 SL eine signifikante Verbesserung bei Fibromyalgie-Schmerzen (p-Wert=0.00005), Schlafqualität, Müdigkeit und allgemeinen Symptomen. Der globale Markt für Fibromyalgie wird voraussichtlich von 2,8 Milliarden Dollar im Jahr 2024 auf 4,13 Milliarden Dollar im Jahr 2032 wachsen. Derzeit sprechen 85 % der Patienten mit Fibromyalgie nicht auf die Erstlinientherapie an und 79 % benötigen mehrere Behandlungen.
Die Entscheidung der FDA über die Annahme des NDA wird für Mitte Dezember 2024 erwartet, mit einer möglichen Genehmigung bis Mitte August 2025.
- Fast Track designation received from FDA, expediting the review process
- Significant positive results in Phase 3 RESILIENT trial with p-value of 0.00005
- Addressing $2.8 billion market expected to grow to $4.13 billion by 2032
- Potential to be first new fibromyalgia drug in over 15 years
- None.
Insights
The NDA submission for TNX-102 SL represents a significant milestone in fibromyalgia treatment development. The p-value of 0.00005 in the RESILIENT trial demonstrates exceptionally strong statistical significance for pain improvement. The potential market opportunity is substantial, with the fibromyalgia market projected to grow from
The drug's novel approach targeting sleep disturbance to address pain, combined with its non-opioid nature, positions it uniquely in a market where
For TNXP, with a market cap of
The market dynamics are particularly favorable, with
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.
CHATHAM, NJ / ACCESSWIRE / December 9, 2024 / Fibromyalgia, the chronic pain condition that plagues approximately ten million Americans is in need of new drug treatment options. The existing approved drugs on the market often aren't enough. Unfortunately, many patients, at the direction of their doctors, end up taking opioids as a last resort to manage fibromyalgia.
Opioids come with their own set of problems. Opioids can be addictive and, over time, life-threatening. Of patients prescribed opioids for chronic pain,
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is on a mission to bring a better drug for fibromyalgia to the market, which is estimated to grow to a value of
Tonix expects to hear a decision on NDA acceptance by the FDA in mid-December. If the NDA is accepted, Tonix said the FDA could commit to a decision on approval in 2025, which means TNX-102 SL could be on the market as early as next year, giving fibromyalgia sufferers a much-needed new non-opioid option. As it stands, Tonix believes
Fast Track Status
The FDA previously granted TNX-102 SL Fast Track designation which expedites the review of important new drugs intended to treat "serious conditions" and address unmet medical needs. Fast Track designation has the goal of bringing new treatments to patients sooner. In granting Fast Track, FDA recognized fibromyalgia as a "serious condition", which shows the recognition that fibromyalgia has achieved recently after being denigrated for so many years by poorly-informed health care providers. Some of these providers distrusted fibromyalgia patients to the extent they believed fibromyalgia "didn't exist". Fortunately, clinical science has progressed and today fibromyalgia is recognized as the prototype for a newly designated type of pain, called "nociplastic pain".
"The Fast Track designation underscores the importance of addressing the unmet needs of fibromyalgia patients," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. Dr. Lederman continued, "Most fibromyalgia patients report dissatisfaction with current drug treatment options. If approved by the FDA, we expect TNX-102 SL to become the first new drug for fibromyalgia in over 15 years."
Targeting Disturbed Sleep to Relieve Pain
Tonix reports that TNX-102 SL is a sublingual formulation of cyclobenzaprine hydrochloride that dissolves under the tongue and is designed to target the sleep problems that typify fibromyalgia. Poor quality sleep can have a big impact on chronic pain. Lack of quality sleep can also hyperexcite the central nervous system (CNS), which can lower pain tolerance.
With TNX-102 SL treatment, patients in Tonix's studies experienced less pain, the company says. In the most recent phase 3 trial, called RESILIENT, TNX-102 SL showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that in the RESILIENT study, significant results were also seen in improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. TNX-102 SL was generally well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablets under the tongue.
Fibromyalgia is the Poster Child of Nociplastic Pain
If the FDA approves TNX-102 SL for fibromyalgia, it could pave the way for the drug to become a first line therapy for fibromyalgia. Fibromyalgia is now recognized as the prototypic nociplastic pain disorder. Nociplastic pain, also known as central sensitization is a type of pain that occurs when the brain processes sensory signals in an altered way, which amplifies how they are perceived. This amplification of sensory information is believed to result in the pain that fibromyalgia patients experience.
Fibromyalgia sufferers around the world are in need of relief. Tonix is hoping that a new treatment option may soon be available. Tonix Pharmaceuticals awaits the FDA decision on NDA acceptance from the FDA for TNX-102 SL. If FDA accepts the NDA in mid-December, that would put the drug on track for an FDA decision on approval in mid-August 2025 for standard review. With millions suffering from the chronic pain of fibromyalgia, this could lead to potential growth for Tonix.
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Contact Information
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
862.904.8182
SOURCE: Tonix Pharmaceuticals Holding
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FAQ
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