As Research Into Pain Accelerates, a Newly Recognized Type of Pain Comes to the Forefront – Tonix Targets It With FDA-Fast Track-Designated TNX-102 SL
Tonix Pharmaceuticals (NASDAQ: TNXP) is developing TNX-102 SL, a potential non-opioid treatment for fibromyalgia, the prototype of nociplastic pain. Nociplastic pain, recently recognized as the third type of pain alongside nociceptive and neuropathic, results from dysfunctional sensory processing by the nervous system. TNX-102 SL, designed to improve sleep quality in fibromyalgia patients, has shown statistically significant improvement in pain reduction in Phase 3 trials. The FDA has granted Fast Track designation for TNX-102 SL, highlighting the urgent need for new fibromyalgia treatments. Tonix plans to submit a New Drug Application (NDA) in the second half of 2024 and may request Priority Review. If approved, TNX-102 SL could become the first new fibromyalgia treatment in over 15 years, offering hope to millions of sufferers.
Tonix Pharmaceuticals (NASDAQ: TNXP) sta sviluppando TNX-102 SL, un potenziale trattamento non oppioide per la fibromialgia, il prototipo del dolore nociplastico. Il dolore nociplastico, recentemente riconosciuto come il terzo tipo di dolore accanto a quello nocicettivo e neuropatico, deriva da un'elaborazione sensoriale disfunzionale da parte del sistema nervoso. TNX-102 SL, progettato per migliorare la qualità del sonno nei pazienti affetti da fibromialgia, ha mostrato un improvement statisticamente significativo nella riduzione del dolore negli studi di Fase 3. La FDA ha concesso la designazione Fast Track per TNX-102 SL, evidenziando l'urgenza di nuovi trattamenti per la fibromialgia. Tonix prevede di presentare una Nuova Richiesta di Farmaco (NDA) nella seconda metà del 2024 e potrebbe richiedere una Revisione Prioritaria. Se approvato, TNX-102 SL potrebbe diventare il primo nuovo trattamento per la fibromialgia negli ultimi 15 anni, offrendo speranza a milioni di persone affette.
Tonix Pharmaceuticals (NASDAQ: TNXP) está desarrollando TNX-102 SL, un posible tratamiento no opioide para la fibromialgia, el prototipo del dolor nociplástico. El dolor nociplástico, reconocido recientemente como el tercer tipo de dolor junto con el nociceptivo y el neuropático, resulta de un procesamiento sensorial disfuncional por parte del sistema nervioso. TNX-102 SL, diseñado para mejorar la calidad del sueño en pacientes con fibromialgia, ha mostrado una mejora estadísticamente significativa en la reducción del dolor en ensayos de Fase 3. La FDA ha otorgado la designación de Vía Rápida para TNX-102 SL, destacando la urgente necesidad de nuevos tratamientos para la fibromialgia. Tonix planea presentar una Solicitud de Nuevo Medicamento (NDA) en la segunda mitad de 2024 y puede solicitar una Revisión Prioritaria. Si se aprueba, TNX-102 SL podría convertirse en el primer nuevo tratamiento para la fibromialgia en más de 15 años, ofreciendo esperanza a millones de personas afectadas.
톤익스 제약회사 (NASDAQ: TNXP)는 TNX-102 SL, 비오피오이드 치료제로서 섬유근육통에 대한 잠재력을 개발하고 있습니다. 최근 nociceptive 및 neuropathic과 함께 제3의 통증 유형으로 인식된 신경가소적 통증은 신경계의 비정상적 감각 처리로 인해 발생합니다. TNX-102 SL은 섬유근육통 환자들의 수면 질을 개선하도록 설계되었으며, 3상 시험에서 통증 감소에 대한 통계적으로 유의한 개선을 보여주었습니다. FDA는 TNX-102 SL에 대해 패스트 트랙 지정을 부여하여 섬유근육통 치료제의 긴급한 필요성을 강조했습니다. 톤익스는 2024년 하반기에 신약 신청서 (NDA)를 제출할 계획이며, 우선 심사를 요청할 수 있습니다. 승인이 된다면 TNX-102 SL은 15년 넘게 처음으로 새로운 섬유근육통 치료제가 되어 수백만 고통받는 사람들에게 희망을 줄 수 있습니다.
Tonix Pharmaceuticals (NASDAQ: TNXP) développe TNX-102 SL, un traitement potentiel non opioïde pour la fibromyalgie, le prototype de la douleur nociplastique. La douleur nociplastique, récemment reconnue comme le troisième type de douleur aux côtés de la douleur nociceptive et neuropathique, résulte d’un traitement sensoriel dysfonctionnel par le système nerveux. TNX-102 SL, conçu pour améliorer la qualité du sommeil chez les patients souffrant de fibromyalgie, a montré une amélioration statistiquement significative de la réduction de la douleur lors des essais de Phase 3. La FDA a accordé la délivrance rapide pour TNX-102 SL, soulignant le besoin urgent de nouveaux traitements pour la fibromyalgie. Tonix prévoit de soumettre une demande de nouveau médicament (NDA) dans la seconde moitié de 2024 et pourrait demander un examen prioritaire. Si elle est approuvée, TNX-102 SL pourrait devenir le premier nouveau traitement pour la fibromyalgie en plus de 15 ans, offrant de l'espoir à des millions de souffrants.
Tonix Pharmaceuticals (NASDAQ: TNXP) entwickelt TNX-102 SL, eine potenzielle nicht-opioide Behandlung für Fibromyalgie, das Prototyp des noxizeptiven Schmerzes. Nociplastischer Schmerz, der kürzlich als dritter Schmerztyp neben noxizeptivem und neuropathischem Schmerz anerkannt wurde, resultiert aus einer fehlerhaften sensorischen Verarbeitung durch das Nervensystem. TNX-102 SL, das entwickelt wurde, um die Schlafqualität bei Fibromyalgie-Patienten zu verbessern, hat in Phase-3-Studien eine statistisch signifikante Verbesserung bei der Schmerzreduktion gezeigt. Die FDA hat Fast-Track-Designation für TNX-102 SL erteilt und damit den dringenden Bedarf an neuen Behandlungsmöglichkeiten für Fibromyalgie hervorgehoben. Tonix plant, in der zweiten Hälfte des Jahres 2024 einen Neuen Arzneimittelantrag (NDA) einzureichen und könnte eine Prioritätsprüfung beantragen. Sofern genehmigt, könnte TNX-102 SL die erste neue Behandlung für Fibromyalgie seit über 15 Jahren werden und Millionen von Betroffenen Hoffnung geben.
- TNX-102 SL showed statistically significant improvement in fibromyalgia pain with a p-value of 0.00005 in Phase 3 trials
- FDA granted Fast Track designation for TNX-102 SL, facilitating development and expediting review
- Tonix plans to submit a New Drug Application (NDA) for TNX-102 SL in the second half of 2024
- TNX-102 SL has no recognized risk of addiction and appears well-tolerated with long-term use
- If approved, TNX-102 SL could be the first new fibromyalgia treatment in over 15 years
- Current FDA-approved drugs for fibromyalgia face widespread dissatisfaction due to poor tolerability and side effects
- Opioids, often prescribed off-label for fibromyalgia, carry risks of addiction and misuse
- TNX-102 SL is still an investigational drug and has not been approved for any indication
Insights
The recognition of nociplastic pain as a distinct type represents a significant advancement in pain research. This third category of pain, characterized by widespread discomfort without apparent tissue damage, sheds light on conditions like fibromyalgia that have long puzzled medical professionals. The potential market for treatments targeting nociplastic pain is substantial, given its chronic nature and the limitations of current therapies.
Tonix's TNX-102 SL, designed to improve sleep quality in fibromyalgia patients, takes an innovative approach by addressing a core symptom that exacerbates pain. The statistically significant results in Phase 3 trials, with a p-value of
The FDA's Fast Track designation for TNX-102 SL is a significant positive signal for Tonix Pharmaceuticals (NASDAQ: TNXP). This designation not only validates the unmet medical need in fibromyalgia treatment but also potentially accelerates the path to market. The planned submission of the New Drug Application (NDA) in the second half of 2024, coupled with the possibility of Priority Review, could lead to a faster-than-average approval process.
Investors should note the substantial market opportunity in fibromyalgia treatment. With over 7 million people globally developing depression and anxiety due to nociplastic pain, a successful, non-addictive treatment could capture significant market share. However, it's important to consider that drug development and approval processes are inherently risky and success is not guaranteed. The company's financial stability and ability to bring the product to market will be key factors to watch.
The fibromyalgia treatment market is ripe for disruption, with current FDA-approved drugs facing widespread dissatisfaction due to poor tolerability and side effects. TNX-102 SL's non-opioid, non-addictive profile positions it favorably in a landscape where opioid prescriptions for fibromyalgia outnumber FDA-approved treatments. This suggests a significant unmet need and potential for market penetration.
The growing recognition of nociplastic pain as a distinct category could expand the addressable market beyond fibromyalgia. If TNX-102 SL proves effective for other nociplastic pain conditions, it could open up additional revenue streams for Tonix. However, market acceptance will depend on the drug's efficacy, safety profile and pricing strategy. The company's ability to effectively educate healthcare providers about nociplastic pain and position TNX-102 SL as a preferred treatment option will be important for commercial success.
CHATHAM, NJ / ACCESSWIRE / September 4, 2024 / (Brain Image)
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.
Research into the causes and nature of pain is accelerating and broadening as evidenced by the more than 400 scientific presentations at the 2024 Word Congress on Pain, held August 6-9 in Amsterdam, which was sponsored by the International Association for the Study of Pain.
The keynote plenary session lecture at the event put a spotlight on what researchers have named nociplastic pain, a third type of pain that is different than the two more well known types of pain, nociceptive (arising from a burn or cut), and neuropathic (arising from pinched or inflamed nerves).
The hallmark of nociplastic (no-see-plastic) pain is the experience of widespread pain in the absence of actual or threatened tissue damage. Nociplastic pain results from dysfunctional processing of sensory experiences by the nervous system. In mechanistic terms, it is a painful experience caused by the altered functioning of pain-related pathways in the peripheral and central nervous system.
Nociplastic pain can occur in isolation, as is the case with fibromyalgia, but an even greater number of people have mixed pain states. It's common for people to become afflicted with nociplastic pain as parts of their body's sensory system break down from years of suffering chronic nociceptive or neuropathic pain1.
"Nociplastic pain is the third primary type of pain and one of the most challenging to treat. Nociplastic pain is always chronic, so treatments need to be suitable for long term use. Tolerability and low-addiction risk are very important. Typical analgesics like NSAIDs and opioids miss the mark because issues with long term tolerability and addiction, respectively," notes Seth Lederman, M.D., CEO of Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), which is developing a new non-addictive treatment for fibromyalgia, the prototypic nociplastic pain syndrome.
He continued, "Think of nociplastic pain as being caused by a software bug in a certain part of the brain that exaggerates sensory experiences and turns them into feelings of real pain."
(Pain Slide Image)
Fibromyalgia was the "Rosetta Stone" that led experts to decipher nociplastic pain and name it. People with fibromyalgia typically hurt all over their bodies, which is consistent with the programming flaw in the part of the brain that interprets all pain. Pain is like an error message, and coming from the brain the error message gets applied to almost all sensations.
The Three Kinds of Pain
--Nociceptive pain is typified by a stubbed toe or appendicitis in which the nervous system is operating normally to warn about tissue injury and prevent further damage. It localizes the injury.
--Neuropathic pain is typified by sciatica or shingles in which nerves are squeezed or infected by a virus. The pain experience can be localized to the injured tissue. But damaged nerves can also transmit location information that may be misleading - for example, in sciatica, pain shoots down the leg, while the problem is in compression on a spinal nerve root. Phantom Limb syndrome is another kind of neuropathic pain that appears to come from a limb that's been amputated.
--Nociplastic pain is the third type of pain, and the most recently defined. Until recently, people with nociplastic pain were treated with skepticism and disbelief because doctors, employers and insurance companies thought they were fabricating symptoms to avoid work, shirk responsibilities and seek benefits. However, nociplastic pain is very real to the patients who experience it2. Moreover, nociplastic pain may be even worse than nociceptive or neuropathic pain in terms of how many people suffer and for how long. More than 7 million people with nociplastic pain globally develop depression and anxiety. It is recognized as a major component of the opioid crisis.
Fibromyalgia is a common chronic pain condition that is the archetype of nociplastic pain.3,4,5 Three drugs are currently approved by the FDA, but patients and providers report widespread dissatisfaction with them due mainly to poor tolerability and off-putting side effects. As a result, doctors prescribe opioids off label more often than the all of the FDA-approved drugs combined.
(FM Graph image)
Opioids bring their own, well-known set of problems. They can be addictive and, over time, even life-threatening. Of patients prescribed opioids for chronic pain,
Tonix is developing TNX-102 SL*, a first-in-class non-opioid treatment for fibromyalgia. Since fibromyalgia is a chronic pain condition, TNX-102 SL is a potential non-opioid analgesic, which is the medical term for "pain killer".
TNX-102 SL is Designed to Treat Fibromyalgia in a New Way
TNX-102 SL is a sublingual formulation of cyclobenzaprine hydrochloride designed to improve sleep quality rather than quantity in fibromyalgia, setting it apart from existing treatments for either fibromyalgia or for sleep disorders.
Traditional sedatives like Ambien fail to manage the type of sleep disturbance that typifies fibromyalgia. Bad sleep worsens pain and pain worsens sleep6,7. Lack of sleep can also hyperexcite the central nervous system (CNS) lower pain tolerance. TNX-102 SL is designed to improve sleep quality in fibromyalgia and in two Phase 3 studies, TNX-102 SL improved nociplastic pain in fibromyalgia, which is the primary endpoint FDA requires to approve a new fibromyalgia drug.
In the latest phase 3 trial, 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 side effects were transient sensations in the mouth corresponding with the disintegration of the tablet under the tongue.
An Urgent Need
The need for new ways to treat fibromyalgia is underscored by the fact that TNX-102 SL was recently granted Fast Track designation by the FDA, which is designed to facilitate development and expedite the review of important new drugs intended to treat serious conditions and address unmet medical needs. Its goal is to 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.
In addition to receiving Fast Track designation, Tonix is finalizing the filing of the New Drug Application (NDA) for TNX-102 SL, which it plans to submit to the FDA in the second half of 2024. Coming out of pre-NDA meetings, Tonix said it is aligned with the FDA regarding 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 NDA.
"The Fast Track designation underscores the importance of addressing the unmet needs of fibromyalgia patients, who report dissatisfaction with current treatment options," said Dr. Lederman. "If approved by the FDA, we expect TNX-102 SL to become the first new pharmacotherapy for fibromyalgia in over 15 years."
Nociplastic pain, whether arises in a pure form from fibromyalgia or in a mixed form from another pathology, is a huge problem in America and beyond, negatively impacting the quality of life for millions of people. Current treatments are often either ineffective or difficult to take over long periods of time because of side-effects. TNX-102 SL, has no recognized risk of addiction and appears to be well tolerated with long term use. Tonix is preparing the NDA which has received FDA Fast Track designation. A new approach to fibromyalgia may mean hope for the millions of Americans who suffer from it.
*TNX-102 SL is an investigational new drug and has not been approved for any indication.
1Wikipedia "Nociplastic pain". https://en.wikipedia.org/wiki/Nociplastic_pain.
2Geddes, L. June 28, 2021 "Sufferers of chronic pain have been told it's all in your head. We now know that's wrong. The Guardian. URL: www.theguardian.com/australia-news/2021/jun/28/sufferers-of-chronic-pain-have-long-been-told-its-all-in-their-head-we-now-know-thats-wrong
3Fitzcharles MA, et al. Nociplastic pain: towards an understanding of prevalent pain conditions. Lancet 2021;397:2098-110
4Clauw DJ. From fibrositis to fibromyalgia to nociplastic pain: how rheumatology helped get us here and where do we go from here? Ann Rheum Dis. Published Online First: 2024
5Kaplan, C.M., Kelleher, E., Irani, A. et al. Deciphering nociplastic pain: clinical features, risk factors and potential mechanisms. Nat Rev Neurol. 2024;20, 347-363
6Moldofsky H, et al. Musculosketal symptoms and non-REM sleep disturbance in patients with "fibrositis syndrome" and healthy subjects. Psychosom Med. 1975;37:341-51
7Moldofsky H, Scarisbrick P. Induction of neurasthenic musculoskeletal pain syndrome by selective sleep stage deprivation. Psychosom Med. 1976;38:35-44
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FAQ
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