The Rush for Non-Addictive Painkillers to Counter the Opioid Crisis Puts Two Companies Close to FDA Decisions
Tonix Pharmaceuticals (NASDAQ:TNXP) is developing TNX-102 SL, a non-opioid drug for fibromyalgia, addressing the urgent need for safer pain management options amid the opioid crisis. The company plans to submit a New Drug Application (NDA) in October 2024, with potential for Priority Review. TNX-102 SL targets disturbed sleep in fibromyalgia patients, offering a novel approach to pain management without addiction risks.
Simultaneously, Vertex Pharmaceuticals has filed an NDA for VX-458, a non-opioid acute pain treatment granted Priority Review by the FDA. These developments reflect a broader industry shift towards non-addictive painkillers, supported by government initiatives like the HEAL Initiative. With an estimated 100 million Americans affected by chronic pain, including 10 million with fibromyalgia, these new treatments could significantly impact pain management practices and help combat the opioid epidemic.
Tonix Pharmaceuticals (NASDAQ:TNXP) sta sviluppando TNX-102 SL, un farmaco non oppioide per la fibromialgia, rispondendo all'urgente necessità di opzioni più sicure per la gestione del dolore in mezzo alla crisi degli oppioidi. L'azienda prevede di presentare una Domanda di Nuovo Farmaco (NDA) a ottobre 2024, con potenziale per una Revisione Prioritaria. TNX-102 SL mira a migliorare il sonno disturbato nei pazienti affetti da fibromialgia, offrendo un approccio innovativo alla gestione del dolore senza i rischi di dipendenza.
Contemporaneamente, Vertex Pharmaceuticals ha presentato una NDA per VX-458, un trattamento non oppioide per il dolore acuto che ha ottenuto la Revisione Prioritaria da parte della FDA. Questi sviluppi riflettono un cambiamento più ampio nel settore verso analgesici non addictivi, supportati da iniziative governative come l'Iniziativa HEAL. Con circa 100 milioni di americani colpiti da dolore cronico, inclusi 10 milioni con fibromialgia, questi nuovi trattamenti potrebbero avere un impatto significativo sulle pratiche di gestione del dolore e contribuire a combattere l'epidemia di oppioidi.
Tonix Pharmaceuticals (NASDAQ:TNXP) está desarrollando TNX-102 SL, un medicamento no opioide para la fibromialgia, abordando la urgente necesidad de opciones más seguras para el manejo del dolor en medio de la crisis de los opioides. La compañía planea presentar una Solicitud de Nuevo Medicamento (NDA) en octubre de 2024, con potencial para una revisión prioritaria. TNX-102 SL se enfoca en los trastornos del sueño en pacientes con fibromialgia, ofreciendo un enfoque novedoso para el manejo del dolor sin riesgos de adicción.
Simultáneamente, Vertex Pharmaceuticals ha presentado una NDA para VX-458, un tratamiento no opioide para el dolor agudo que ha recibido revisión prioritaria por parte de la FDA. Estos desarrollos reflejan un cambio más amplio en la industria hacia analgésicos no adictivos, apoyados por iniciativas gubernamentales como la Iniciativa HEAL. Con aproximadamente 100 millones de estadounidenses afectados por dolor crónico, incluyendo 10 millones con fibromialgia, estos nuevos tratamientos podrían tener un impacto significativo en las prácticas de manejo del dolor y ayudar a combatir la epidemia de opioides.
토닉스 제약(Tonix Pharmaceuticals, NASDAQ:TNXP)은 TNX-102 SL이라는 비오피오이드 약물을 개발하고 있으며, 이는 섬유근육통에 대한 안전한 통증 관리 옵션의 긴급한 필요성을 해결하려는 것입니다. 이 회사는 2024년 10월에 신약 신청서(NDA)를 제출할 계획이며, 우선 심사 가능성이 있습니다. TNX-102 SL은 섬유근육통 환자의 수면 문제를 목표로 하여 중독 위험 없이 통증 관리를 위한 새로운 접근 방식을 제공합니다.
동시에 버텍스 제약(Vertex Pharmaceuticals)은 우선 심사를 받은 비오피오이드 급성 통증 치료제 VX-458에 대한 NDA를 제출했습니다. 이러한 발전은 정부의 HEAL 이니셔티브와 같은 지원을 받아 중독성이 없는 진통제로의 산업 전반의 변화를 반영합니다. 약 1억 명의 미국인이 만성 통증에 시달리고 있으며, 그 중 1000만 명이 섬유근육통을 앓고 있어 이러한 새로운 치료법이 통증 관리 관행에 중대한 영향을 미치고 오피오이드 전염병에 맞서 싸우는 데 도움이 될 수 있습니다.
Tonix Pharmaceuticals (NASDAQ:TNXP) développe TNX-102 SL, un médicament non opioïde pour la fibromyalgie, répondant à l'urgence d'options de gestion de la douleur plus sûres au milieu de la crise des opioïdes. L'entreprise prévoit de soumettre une Demande d'Autorisation de Mise sur le Marché (NDA) en octobre 2024, avec un potentiel de Révision Prioritaire. TNX-102 SL cible les troubles du sommeil chez les patients fibromyalgiques, offrant une approche novatrice pour la gestion de la douleur sans risques de dépendance.
En parallèle, Vertex Pharmaceuticals a déposé une NDA pour VX-458, un traitement non opioïde pour la douleur aiguë bénéficiant d'une Révision Prioritaire de la part de la FDA. Ces développements reflètent un changement plus large dans l'industrie vers des analgésiques non additifs, soutenus par des initiatives gouvernementales comme l'Initiative HEAL. Avec environ 100 millions d'Américains touchés par des douleurs chroniques, dont 10 millions avec fibromyalgie, ces nouveaux traitements pourraient avoir un impact significatif sur les pratiques de gestion de la douleur et aider à lutter contre l'épidémie d'opioïdes.
Tonix Pharmaceuticals (NASDAQ:TNXP) entwickelt TNX-102 SL, ein nicht-opioides Medikament gegen Fibromyalgie, um dem dringenden Bedarf an sichereren Schmerzmanagement-Optionen im Zuge der Opioidkrise gerecht zu werden. Das Unternehmen plant, im Oktober 2024 einen Antrag auf Zulassung neuer Arzneimittel (NDA) einzureichen, mit der Möglichkeit einer Prioritätsprüfung. TNX-102 SL zielt auf gestörten Schlaf bei Fibromyalgie-Patienten ab und bietet einen neuartigen Ansatz zur Schmerzbewältigung ohne Suchtgefahr.
Gleichzeitig hat Vertex Pharmaceuticals einen NDA für VX-458, eine nicht-opioide Behandlung für akute Schmerzen, eingereicht, die von der FDA eine Prioritätsbewertung erhalten hat. Diese Entwicklungen spiegeln einen breiteren Wandel in der Branche hin zu nicht-suchtgefährdenden Schmerzmitteln wider, unterstützt durch staatliche Initiativen wie die HEAL-Initiative. Mit schätzungsweise 100 Millionen Amerikanern, die von chronischen Schmerzen betroffen sind, darunter 10 Millionen mit Fibromyalgie, könnten diese neuen Behandlungen erhebliche Auswirkungen auf die Schmerzmanagementpraktiken haben und zur Bekämpfung der Opioid-Epidemie beitragen.
- Tonix plans to submit NDA for TNX-102 SL in October 2024, potentially offering the first new fibromyalgia treatment in over 15 years
- TNX-102 SL received FDA Fast Track designation for fibromyalgia
- Tonix will request Priority Review for TNX-102 SL, which could expedite the regulatory process
- TNX-102 SL targets sleep disturbance in fibromyalgia, offering a new mechanism of action without opioid risks
- Tonix's TNX-102 SL is still an investigational drug and not yet approved for any indication
- Previous attempts to introduce new pain treatments have faced regulatory challenges or unforeseen side effects
Insights
Tonix Pharmaceuticals' TNX-102 SL represents a significant advancement in non-opioid pain management for fibromyalgia. The drug's novel mechanism targeting sleep disturbance addresses a critical aspect of fibromyalgia pathophysiology. With 10 million Americans affected by fibromyalgia and effective treatments, TNX-102 SL could fill a substantial unmet need.
The upcoming NDA submission in October 2024 and potential Priority Review could accelerate market entry. If approved, TNX-102 SL would be the first new fibromyalgia treatment in over 15 years. This timing aligns well with increasing demand for non-addictive pain solutions amid the opioid crisis.
However, investors should note that regulatory approval is not guaranteed and market adoption may face challenges from established treatments. The
Tonix Pharmaceuticals (NASDAQ:TNXP) is positioning itself strategically in the evolving pain management market. With a market cap of
The fibromyalgia market represents a substantial opportunity, given the 10 million affected individuals in the U.S. Successful commercialization could drive significant revenue growth for Tonix. However, investors should consider the risks associated with the regulatory process and potential competition from other emerging non-opioid treatments.
The company's focus on non-addictive pain solutions aligns with government initiatives and market demand, which could attract partnerships or acquisition interest from larger pharmaceutical companies. The stock's current valuation may not fully reflect the potential upside of TNX-102 SL's success, presenting a high-risk, high-reward opportunity for investors comfortable with biotech sector volatility.
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 / October 1, 2024 / As the opioid crisis continues to devastate communities and strain healthcare systems, the demand for safer, non-addictive pain management options remains urgent. Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) is looking to be at the forefront of this shift, developing an innovative solution that could reshape chronic pain treatment. Central to Tonix's strategy is TNX-102 SL*, a non-opioid investigational drug targeting fibromyalgia, a chronic pain condition that affects millions of Americans.
Tonix is one of several biopharmaceutical companies responding to the call for non-addictive painkillers. The FDA's Fast Track designation of TNX-102 SL for fibromyalgia highlights the critical need for new treatments in chronic pain management. The FDA has granted Priority Review status to VX-458 from Vertex Pharmaceuticals. VX-458 is a non-opioid drug for acute pain.
The Market is Ready for Non-Opioid Pain Solutions
The broader pain management market has faced numerous setbacks in recent years. Past attempts to introduce new treatments have often been met with regulatory challenges or unforeseen side effects. For instance, anti-NGF monoclonal antibodies, pursued by pharmaceutical giants like Pfizer and Eli Lilly, Johnson and Johnson and AstraZeneca did not achieve their desired results due to increased risks of joint damage. Before that, painkillers like Vioxx from Merck and Celebrex from Pfizer were challenged for heart attack and stroke risks, even prompting Merck to enact a global product withdrawal for Vioxx.
Chronic pain is a complex and often debilitating condition, affecting an estimated 100 million Americans, with fibromyalgia and long COVID contributing millions each to that count. Fibromyalgia, a common chronic pain condition, impacts approximately 10 million people in the U.S. alone. Fibromyalgia was long overlooked because it affects mostly women and the medical establishment and pharmaceutical industry did not historically focus on health issues affecting mostly women. Even today, the three FDA-approved treatments for fibromyalgia are limited by side-effects, and many patients resort to opioids, despite their risks. In fact, research indicates that
Tonix Pharmaceuticals aims to change this with TNX-102 SL, a first-in-class non-opioid drug designed to target the disturbed sleep in fibromyalgia, which the company believes is closely linked to origins of pain in fibromyalgia patients. By addressing sleep disturbance, TNX-102 SL offers a new mechanism of action from existing treatments for managing fibromyalgia pain without the dangers of opioids.
Tonix is nearing the submission of its new drug application (NDA) for TNX-102 SL, which is expected in October 2024 - just weeks from now. The company plans to request Priority Review, which could expedite the regulatory process and bring the treatment to market sooner. If approved, Tonix reports that TNX-102 SL would be the first new pharmacotherapy for fibromyalgia in more than 15 years, offering a groundbreaking option for patients who have long struggled with inadequate treatment options.
The Push for Non-Addictive Painkillers
Tonix's TNX-102 SL is part of a broader movement within the pharmaceutical industry to develop non-addictive pain treatments. This shift is being driven, in part, by the federal government's focus on curbing opioid addiction, which has become a public health emergency. In 2020 alone, the opioid epidemic cost the U.S. economy an estimated
Recognizing the dangers of opioid use, the U.S. government has been actively encouraging the development of alternatives such as through initiatives like the HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort that is funding more than 1,000 projects nationwide to speed scientific solutions to stem the national opioid public health crisis.
While Tonix's TNX-102 SL focuses on chronic pain management, Vertex's VX-458 addresses acute pain, a market that includes over 80 million U.S. patients annually, according to Vertex's estimates. VX-458 is a non-opioid treatment that interrupts pain signaling without engaging opioid receptors, significantly reducing the risk of addiction. Vertex has already filed the NDA for VX-458 based on pain relief in surgical studies of bunionectomy and abdominoplasty or "tummy tuck". The FDA has granted VX-458 Priority Review status, signaling its importance in addressing the acute pain market. Both Tonix and Vertex's efforts represent potentially crucial steps in reducing opioid reliance for chronic and acute pain, respectively.
Navigating the Complex World of Pain
Understanding pain and how to treat it effectively requires recognizing its complexity. Pain is not a one-size-fits-all experience - it varies in duration and type. Pain can be acute or chronic. Also, three distinct types of pain are recognized, and each type responds to different medicines. Fibromyalgia represents one of the most challenging forms of pain because it is the prototypic example of nociplastic pain, which has only been recognized by scientists in the past few years. Noicplastic pain is always chronic. Nociplastic pain originates in the brain and only responds to drugs that act in the brain. Tonix's TNX-102 SL acts on nociplastic pain in the brain.
In contrast, there are two types of pain that originate in the periphery, or outside the brain. The "periphery" means arms, legs and even organs. Nociceptive pain is the type that signals real or impending tissue damage. Nociceptive pain can be acute or chronic. Nociceptive pain represents the normal functioning of the pain system. Nociceptive pain is the target for Vertex's VX-458, which targets a protein in the body called NaV1.8, expressed in peripheral tissues, which is mutated in people who cannot experience pain and subsequently lose fingers and toes.
The final type of pain is called neuropathic pain, and stems from nerve damage, like sciatica or shingles. Neuropathic pain is relatively well-understood and is typically treated by relieving the problem that's damaging the nerve. For sciatica this may involve surgery to relieve the nerve compression. For shingles, this may involve treating the zoster infection with medicines for herpes.
Fibromyalgia represents one of the most challenging forms of nociplastic pain because it is widespread and often unrelenting. Also, fibromyalgia is typically associated with sleep disturbance and fatigue. Traditional treatments, including opioids, have been insufficient in addressing this type of pain. Opioid misuse has worsened the problem, as many patients turn to these drugs for relief despite the lack of evidence supporting their efficacy in treating fibromyalgia.
Tonix's TNX-102 SL offers a promising alternative by focusing on targeting disturbed sleep, which plays a crucial role in how the brain processes pain signals. Research shows that improved sleep quality is strongly associated with reduced pain in fibromyalgia patients. This approach distinguishes TNX-102 SL from currently common therapies and potentially represents a much-needed advance in the management of fibromyalgia's chronic pain. Tonix intends to apply for Priority Review next month (in October) at the time of filing the NDA for TNX-102 SL for fibromyalgia.
These treatments reflect how new science and the commitment of industry and academia can be mobilized to bring non-opioid treatments to market. Both Tonix's TNX-102 SL and Vertex's VX-458 have received FDA Fast Track designations. These designations are granted to important new drugs that address serious medical conditions and have the potential to fill unmet medical needs.
The Future of Pain Management?
The momentum behind non-addictive pain relief solutions is undeniable. As the opioid crisis continues to claim lives, the need for safer alternatives becomes increasingly urgent.
Tonix's commitment to developing the non-addictive TNX-102 SL drug for the chronic pain condition fibromyalgia aligns with growing demand from both patients and regulators for safer options. The active ingredient of TNX-102 SL acts in the brain, which is believed to be the origin of fibromyalgia's nociplastic pain.
In parallel, Vertex's development of VX-458 which acts in the periphery for the acute pain space reinforces the growing momentum for non-opioid solutions across the pain spectrum. As both companies advance their respective treatments, the future of pain management looks increasingly promising, with patients potentially poised to benefit from safer, more effective therapies.
The time has come for new classes of non-addictive painkillers, and Tonix's strategic position with TNX-102 SL potentially places it at the forefront of this critical shift. As the opioid crisis continues to drive demand for safer pain management solutions, Tonix may be set to play a pivotal role in shaping the future of chronic pain treatment.
*TNX-102 SL is an investigational new drug and is not approved for any indication
Featured photo by Gizem Nikomedi on Unsplash
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Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182
Contact Information
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
862.904.8182
SOURCE: Tonix Pharmaceuticals Holding
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FAQ
When is Tonix Pharmaceuticals (TNXP) submitting the NDA for TNX-102 SL?
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How does Tonix Pharmaceuticals' (TNXP) TNX-102 SL differ from existing fibromyalgia treatments?
