FDA Recognizes Fibromyalgia as a 'Serious Condition' And Fast-Tracks New Drug Candidate
The FDA has granted Fast Track designation to Tonix Pharmaceuticals (NASDAQ:TNXP) for TNX-102 SL, a drug candidate for managing fibromyalgia. This recognition underscores fibromyalgia as a serious condition affecting over 10 million Americans. The global fibromyalgia treatment market is projected to reach $3.86 billion by 2031, growing at a 3.3% CAGR. TNX-102 SL, a non-addictive sublingual formulation of cyclobenzaprine hydrochloride, showed significant improvement in fibromyalgia pain in Phase 3 trials. Tonix plans to submit a New Drug Application (NDA) in the second half of 2024, potentially becoming the first new fibromyalgia pharmacotherapy in over 15 years.
La FDA ha concesso la designazione di Fast Track a Tonix Pharmaceuticals (NASDAQ:TNXP) per il TNX-102 SL, un candidato farmaco per la gestione della fibromialgia. Questo riconoscimento sottolinea la fibromialgia come una condizione seria che colpisce oltre 10 milioni di americani. Si prevede che il mercato globale dei trattamenti per la fibromialgia raggiunga $3,86 miliardi entro il 2031, con una crescita del 3,3% CAGR. TNX-102 SL, una formulazione sublinguale non addictiva di cloridrato di ciclobenzaprina, ha mostrato un miglioramento significativo nel dolore da fibromialgia nelle sperimentazioni di Fase 3. Tonix prevede di presentare una Domanda di Nuovo Farmaco (NDA) nella seconda metà del 2024, con la possibilità di diventare la prima nuova farmacoterapia per la fibromialgia in oltre 15 anni.
La FDA ha otorgado la designación de Fast Track a Tonix Pharmaceuticals (NASDAQ:TNXP) para TNX-102 SL, un candidato a medicamento para el manejo de la fibromialgia. Este reconocimiento subraya la fibromialgia como una condición grave que afecta a más de 10 millones de estadounidenses. Se proyecta que el mercado global de tratamientos para la fibromialgia alcanzará $3,86 mil millones para 2031, con un crecimiento del 3,3% CAGR. TNX-102 SL, una formulación sublingual no adictiva de clorhidrato de ciclobenzaprina, mostró una mejora significativa en el dolor de fibromialgia en ensayos de Fase 3. Tonix planea presentar una Solicitud de Nuevo Medicamento (NDA) en la segunda mitad de 2024, lo que podría convertirlo en la primera nueva farmacoterapia para la fibromialgia en más de 15 años.
FDA는 Tonix Pharmaceuticals (NASDAQ:TNXP)의 TNX-102 SL에 패스트 트랙 지정을 부여했습니다. 이는 섬유근육통 관리를 위한 후보 약물입니다. 이 인정은 섬유근육통이 1천만 명 이상의 미국인에게 영향을 미치는 심각한 질환이라는 점을 강조합니다. 전 세계 섬유근육통 치료 시장은 2031년까지 38억 6천만 달러에 이를 것으로 예상되며, 연평균 3.3% 성장할 것으로 보입니다. TNX-102 SL은 비중독성 설하 제형의 클로르프레닌염산염으로, 3상 시험에서 섬유근육통 통증에 대한 유의미한 개선을 보였습니다. Tonix는 2024년 하반기 중에 신규 의약품 신청(NDA)을 제출할 계획이며, 이는 15년 이상 만에 최초의 새로운 섬유근육통 약물이 될 가능성이 있습니다.
La FDA a accordé la désignation Fast Track à Tonix Pharmaceuticals (NASDAQ:TNXP) pour TNX-102 SL, un candidat médicament pour la gestion de la fibromyalgie. Cette reconnaissance souligne que la fibromyalgie est une condition grave qui touche plus de 10 millions d'Américains. Le marché mondial des traitements de la fibromyalgie devrait atteindre 3,86 milliards de dollars d'ici 2031, avec une croissance de 3,3 % en moyenne annuelle. TNX-102 SL, une formulation sublinguale non addictive de chlorhydrate de cyclobenzaprines, a montré une amélioration significative de la douleur fibromyalgique lors des essais de Phase 3. Tonix prévoit de soumettre une Demande de Médicament Nouveau (NDA) au cours de la seconde moitié de 2024, ce qui pourrait en faire la première nouvelle pharmacothérapie pour la fibromyalgie en plus de 15 ans.
Die FDA hat Tonix Pharmaceuticals (NASDAQ:TNXP) für TNX-102 SL, ein Arzneimittelkandidat zur Behandlung der Fibromyalgie, die Fast Track-Designation erteilt. Diese Anerkennung unterstreicht, dass Fibromyalgie eine ernste Erkrankung ist, die über 10 Millionen Amerikaner betrifft. Der globale Markt für Fibromyalgietherapien wird voraussichtlich bis 2031 3,86 Milliarden Dollar erreichen und mit einem CAGR von 3,3% wachsen. TNX-102 SL, eine nicht süchtig machende sublinguale Formulierung von Cyclobenzaprin-Hydrochlorid, zeigte in klinischen Phase-3-Studien eine signifikante Verbesserung der Schmerzen bei Fibromyalgie. Tonix plant, in der zweiten Hälfte des Jahres 2024 einen Neue Arzneimittelantrag (NDA) einzureichen, was möglicherweise die erste neue Pharmakotherapie für Fibromyalgie seit über 15 Jahren wäre.
- FDA granted Fast Track designation for TNX-102 SL, potentially expediting its development and review
- TNX-102 SL showed statistically significant improvement in fibromyalgia pain in Phase 3 trials (p-value 0.00005)
- Global fibromyalgia treatment market projected to reach $3.86 billion by 2031, growing at 3.3% CAGR
- TNX-102 SL is non-addictive, addressing concerns about opioid use in pain management
- Tonix plans to submit NDA in second half of 2024, potentially becoming first new fibromyalgia treatment in over 15 years
- TNX-102 SL is still an investigational drug and not yet approved for any indication
- Potential competition in the growing fibromyalgia treatment market
Insights
The FDA's recognition of fibromyalgia as a 'serious condition' and the Fast Track designation for TNX-102 SL are significant developments in the field of chronic pain management. This decision underscores the severity of fibromyalgia and the urgent need for effective treatments.
Key points to consider:
- Fibromyalgia affects over 10 million people in the U.S. and 3-6% of the global population, highlighting the substantial market potential for effective treatments.
- The projected growth of the fibromyalgia treatment market to
$3.86 billion by 2031 at a CAGR of3.3% indicates a steady demand for new therapies. - TNX-102 SL's focus on improving sleep quality rather than quantity is a novel approach that addresses a critical aspect of fibromyalgia management often overlooked by current treatments.
- The statistically significant improvement in fibromyalgia pain (p-value of 0.00005) in Phase 3 trials is particularly noteworthy, suggesting potential clinical efficacy.
However, it's important to note that while promising, TNX-102 SL is still an investigational drug. The upcoming NDA submission and potential Priority Review will be important milestones to watch. If approved, TNX-102 SL could potentially disrupt the current treatment landscape, especially given its non-addictive properties in contrast to commonly prescribed opioids.
The Fast Track designation for Tonix Pharmaceuticals' TNX-102 SL represents a significant milestone with potential financial implications:
- Fast Track status could accelerate the drug's path to market, potentially leading to earlier revenue generation for Tonix.
- The fibromyalgia treatment market's projected growth to
$3.86 billion by 2031 presents a substantial opportunity for Tonix if TNX-102 SL gains approval. - As the first new pharmacotherapy for fibromyalgia in over 15 years, TNX-102 SL could capture a significant market share, especially given the reported dissatisfaction with current treatment options.
- The non-addictive nature of TNX-102 SL could position it favorably against opioid-based treatments, potentially leading to broader adoption and sustained revenue growth.
However, investors should be cautious:
- The drug is still investigational and FDA approval is not guaranteed.
- Even with Fast Track designation, the timeline to market can be unpredictable.
- Competition in the fibromyalgia market may intensify as other companies recognize the market potential.
Tonix's progress with the NDA submission and potential Priority Review request are positive indicators, but the company's financial performance will ultimately depend on successful commercialization if TNX-102 SL receives approval.
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 / August 1, 2024 / When it comes to chronic pain conditions, fibromyalgia is among the most common, afflicting more than ten million people in the United States. Globally, 3
With so many people suffering from a disease that brings widespread pain, fatigue and cognitive issues, it's no wonder the market for symptom treatment has seen steady growth over the years and is poised for more. By 2031, the fibromyalgia treatment market is projected to reach
Fibromyalgia is a Serious Disease
This form of chronic pain has become such a problem in the United States that the Food & Drug Administration (FDA) considers the disease to be a serious condition, which means it is a disease associated with morbidity that has a substantial impact on day-to-day functioning. After all,
Most treatments on the market today are a combination of medication and self-care focused on reducing symptoms and improving the quality of life. Unfortunately, due to dissatisfaction with the available treatment options, many patients (at the direction of their medical providers) turn to opioids to relieve their pain. As it stands, more people diagnosed with fibromyalgia are prescribed opioids than the bestselling FDA-approved drug duloxetine (generic Cymbalta). That's concerning, given opioids can be addictive and with time, life-threatening.
Of patients prescribed opioids for chronic pain,
Fast Track Granted to TNX-102 SL*
The FDA has granted Tonix Pharmaceuticals (NASDAQ:TNXP) a fully integrated biopharmaceutical company Fast Track designation for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), its drug candidate for the management of fibromyalgia. Tonix says the designation validates that fibromyalgia is a serious condition and that TNX-102 SL, which has no known addictive properties, has the potential to address this unmet medical need.
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 get new treatments to patients sooner. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development.
"The designation underscores the importance of addressing the unmet needs of fibromyalgia patients, who report dissatisfaction with current treatment options," said Seth Lederman, M.D., CEO of Tonix Pharmaceuticals. "If approved by the FDA, we expect TNX-102 SL to become the first new pharmacotherapy for fibromyalgia in over 15 years."
TNX-102 SL is a sublingual formulation of cyclobenzaprine hydrochloride designed to improve sleep quality rather than quantity, setting it apart from existing treatments, which fail to manage sleep disturbances that exacerbate fibromyalgia symptoms, the company says.
In recent Phase 3 trials, TNX-102 SL showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that significant results were also seen in improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. TNX-102 SL was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablet under the tongue.
New Drug Application Coming Soon
In addition to receiving Fast Track status, Tonix announced it is making progress on its new drug application (NDA), which it plans to submit to the FDA in the second half of this year. Coming out of pre-NDA meetings, Tonix said it is aligned with the FDA regarding the application for TNX-102 SL.
Tonix plans to request Priority Review designation for TNX-102 SL, and if granted, the FDA may accelerate the review of the new drug application.
"The NDA being prepared supports TNX-102 SL's potential position as a first-line non-addictive therapy for fibromyalgia, indicated for long-term daily use at bedtime," said Lederman.
*TNX-102 SL is an investigational new drug and has not been approved for any indication.
Featured photo by B-Me on Pixabay
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SOURCE: Tonix Pharmaceuticals Holding Corp.
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