Tharimmune Advances TH104 for Prophylaxis Against Weaponized Fentanyl and Other High-Potency Opioids Following Positive FDA Feedback
Tharimmune (NASDAQ:THAR) received positive FDA feedback for TH104, a buccal film formulation of nalmefene designed for prophylaxis against weaponized fentanyl and high-potency opioids. The FDA confirmed no additional clinical trials are needed before a 505(b)(2) New Drug Application submission.
TH104 is specifically developed for military personnel and chemical incident responders who may face exposure to weaponized opioids. The product offers rapid absorption and potential liver metabolism bypass, addressing a critical need identified in the United States Strategic National Stockpile (SNS) market assessment.
The development aligns with increasing U.S. government recognition of fentanyl-related compounds as national security threats, particularly following historical incidents like the 2002 Moscow theater crisis. The SNS currently maintains over 1974 containers in 1330 locations nationwide for chemical threat response.
Tharimmune (NASDAQ:THAR) ha ricevuto un riscontro positivo dalla FDA per TH104, una formulazione in film buccale di nalmefene progettata per la profilassi contro il fentanyl militarizzato e gli oppioidi ad alta potenza. La FDA ha confermato che non sono necessari ulteriori studi clinici prima della presentazione di una domanda di nuovo farmaco 505(b)(2).
TH104 è stato sviluppato specificamente per il personale militare e gli operatori di intervento in incidenti chimici che potrebbero essere esposti a oppioidi militarizzati. Il prodotto offre un'assorbimento rapido e un potenziale bypass del metabolismo epatico, rispondendo a un bisogno critico identificato nella valutazione del mercato dello Strategic National Stockpile (SNS) degli Stati Uniti.
Lo sviluppo è in linea con il crescente riconoscimento da parte del governo statunitense delle sostanze correlate al fentanyl come minacce alla sicurezza nazionale, soprattutto dopo eventi storici come la crisi del teatro di Mosca nel 2002. Attualmente, lo SNS mantiene oltre 1974 contenitori in 1330 sedi a livello nazionale per la risposta alle minacce chimiche.
Tharimmune (NASDAQ:THAR) recibió una respuesta positiva de la FDA para TH104, una formulación en película bucal de nalmefeno diseñada para la profilaxis contra el fentanilo militarizado y opioides de alta potencia. La FDA confirmó que no se requieren ensayos clínicos adicionales antes de la presentación de una solicitud de nuevo medicamento 505(b)(2).
TH104 fue desarrollado específicamente para personal militar y respondedores a incidentes químicos que puedan estar expuestos a opioides militarizados. El producto ofrece una rápida absorción y un posibleudir el metabolismo hepático, atendiendo una necesidad crítica identificada en la evaluación del mercado del Strategic National Stockpile (SNS) de Estados Unidos.
El desarrollo está alineado con el creciente reconocimiento del gobierno de EE. UU. de los compuestos relacionados con el fentanilo como amenazas a la seguridad nacional, especialmente tras incidentes históricos como la crisis del teatro de Moscú en 2002. Actualmente, el SNS mantiene más de 1974 contenedores en 1330 ubicaciones a nivel nacional para la respuesta a amenazas químicas.
Tharimmune (NASDAQ:THAR)은 무기화된 펜타닐 및 고효능 오피오이드에 대한 예방 목적으로 설계된 나멜페네의 구강 점막 필름 제형인 TH104에 대해 FDA로부터 긍정적인 피드백을 받았습니다. FDA는 505(b)(2) 신약 신청서 제출 전에 추가 임상시험이 필요하지 않다고 확인했습니다.
TH104는 군인 및 화학 사고 대응 요원을 위해 특별히 개발되었으며, 이들이 무기화된 오피오이드에 노출될 위험에 대비합니다. 이 제품은 빠른 흡수와 잠재적인 간 대사 우회 효과를 제공하여 미국 전략 국가 비축물자(SNS) 시장 평가에서 확인된 중요한 필요를 충족합니다.
이 개발은 2002년 모스크바 극장 위기와 같은 역사적 사건 이후 펜타닐 관련 화합물을 국가 안보 위협으로 인식하는 미국 정부의 증가하는 움직임과 일치합니다. SNS는 현재 전국 1330개 장소에 1974개 이상의 컨테이너를 화학 위협 대응용으로 보유하고 있습니다.
Tharimmune (NASDAQ:THAR) a reçu un retour positif de la FDA concernant TH104, une formulation en film buccal de nalméfène conçue pour la prophylaxie contre le fentanyl militarisé et les opioïdes à haute puissance. La FDA a confirmé qu'aucun essai clinique supplémentaire n'est nécessaire avant la soumission d'une demande de nouveau médicament 505(b)(2).
TH104 est spécifiquement développé pour le personnel militaire et les intervenants en cas d'incidents chimiques susceptibles d'être exposés à des opioïdes militarisés. Le produit offre une absorption rapide et un contournement potentiel du métabolisme hépatique, répondant à un besoin crucial identifié dans l'évaluation du marché du Strategic National Stockpile (SNS) des États-Unis.
Ce développement s'aligne avec la reconnaissance croissante par le gouvernement américain des composés liés au fentanyl comme menaces pour la sécurité nationale, notamment après des événements historiques tels que la crise du théâtre de Moscou en 2002. Le SNS maintient actuellement plus de 1974 conteneurs dans 1330 sites à travers le pays pour la réponse aux menaces chimiques.
Tharimmune (NASDAQ:THAR) erhielt positives Feedback von der FDA für TH104, eine buccale Filmformulierung von Nalmefen, die zur Prophylaxe gegen bewaffnetes Fentanyl und hochpotente Opioide entwickelt wurde. Die FDA bestätigte, dass vor der Einreichung eines 505(b)(2)-Neuartikels keine weiteren klinischen Studien erforderlich sind.
TH104 wurde speziell für Militärpersonal und Einsatzkräfte bei chemischen Zwischenfällen entwickelt, die einer Exposition gegenüber bewaffneten Opioiden ausgesetzt sein könnten. Das Produkt bietet eine schnelle Absorption und eine mögliche Umgehung des Leberstoffwechsels, womit ein kritischer Bedarf adressiert wird, der in der Marktanalyse des Strategic National Stockpile (SNS) der USA identifiziert wurde.
Die Entwicklung steht im Einklang mit der zunehmenden Anerkennung fentanylhaltiger Verbindungen als nationale Sicherheitsbedrohung durch die US-Regierung, insbesondere nach historischen Ereignissen wie der Theaterkrise in Moskau 2002. Das SNS unterhält derzeit über 1974 Behälter an 1330 Standorten landesweit für die Reaktion auf chemische Bedrohungen.
- FDA confirmation of no additional clinical trials needed for NDA submission accelerates approval timeline
- Product addresses critical national security need identified by Strategic National Stockpile
- Unique buccal delivery system offers advantages over existing intramuscular injections
- Potential government procurement opportunity through DoD and SNS programs
- Product still pending regulatory approval with no guaranteed timeline
- Dependent on government contracts and procurement decisions
- Competition from existing naloxone-based solutions in the market
Insights
FDA clearing TH104 to proceed directly to NDA represents substantial time/cost savings on pathway to potential government contracts.
The FDA's feedback that no additional clinical trials are necessary for TH104's 505(b)(2) New Drug Application represents a significant regulatory breakthrough for Tharimmune. This regulatory pathway strategically leverages existing safety data for nalmefene while requiring evidence that the novel buccal film formulation delivers the drug effectively. The 505(b)(2) route is precisely designed for reformulations like TH104, potentially saving millions in development costs and 1-2 years of development time.
For a prophylactic countermeasure against weaponized opioids, the pharmacokinetic profile is critical. TH104's buccal film design allows for rapid absorption while potentially bypassing first-pass metabolism, creating a pharmacokinetic profile optimized for emergency scenarios where rapid onset is essential. This delivery system offers clear advantages for military personnel in protective gear where traditional injection-based countermeasures present logistical challenges.
This regulatory clarity eliminates a major development hurdle, providing Tharimmune with a defined path to commercialization. With the NDA submission now the next major milestone, the company can focus resources on completing required chemistry, manufacturing, and controls (CMC) work rather than costly additional clinical studies.
TH104 addresses an explicitly identified national security concern, with the U.S. government actively seeking medical countermeasures against weaponized fentanyl and high-potency opioids. The product aligns perfectly with a strategic shift toward prophylactic protection for military personnel and chemical incident responders, rather than solely reactive treatment after exposure.
The Strategic National Stockpile infrastructure - maintaining 1974 containers across 1330 locations nationwide - demonstrates the scale of potential government procurement. This existing distribution framework offers a clear commercialization pathway if TH104 receives approval. The Department of Defense is already procuring naloxone auto-injectors specifically for opioid prophylaxis, confirming established budget allocation and procurement mechanisms for such countermeasures.
The Moscow theater crisis precedent referenced in the article demonstrates the real-world threat driving government interest, while TH104's buccal film technology offers operational advantages over injectable formulations for personnel wearing protective equipment. For Tharimmune, this represents potential entry into the specialized chemical defense countermeasures market, which typically features long-term government contracts with predictable revenue streams and less price sensitivity than traditional pharmaceutical markets.
BRIDGEWATER, NEW JERSEY / ACCESS Newswire / April 28, 2025 / Tharimmune, Inc., (Nasdaq:THAR) ("Tharimmune" or the "Company") a clinical-stage biopharmaceutical company focused on developing innovative therapeutics in inflammation & immunology, recently announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding TH104. The agency confirmed that no additional clinical trials appear to be necessary prior to a 505(b)(2) New Drug Application (NDA) submission. TH104 is a buccal film formulation, of nalmefene specifically designed for rapid absorption with a potential for bypassing liver metabolism. This allows TH104 to be suitable for the temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders who may be exposed to high-potency opioids, including weaponized fentanyl and its analogues.
This significant regulatory milestone underscores the urgent need for specialized medical countermeasures highlighted in a recent market assessment concerning the United States Strategic National Stockpile (SNS). This assessment specifically addressed the growing threat posed by chemicals of concern, with a primary focus on the increasing risk of high-potency synthetic opioids like fentanyl and its numerous derivatives being weaponized and deployed as aerosolized agents.
The U.S. government has increasingly recognized fentanyl and its related compounds as significant national security threats due to their extreme potency and the potential for mass casualty incidents if weaponized. These substances, significantly more potent than traditional opioids, pose a grave risk through inhalation, dermal contact, or ingestion. The 2002 Moscow theater hostage crisis, where aerosolized synthetic opioids were reportedly used, tragically demonstrated the devastating potential of such agents in a mass casualty scenario. This event, alongside intelligence indicating potential adversary interest in opioid-based chemical weapons, has heightened the priority for developing effective prophylactic measures for frontline personnel/first responders.
SNS market assessment identified a critical need for countermeasures that can be administered prior to or immediately upon potential exposure to these agents, preventing or mitigating the rapid onset of respiratory and nervous system depression. Key findings from this analysis further emphasize the importance of Tharimmune's work:
DoD Focus on Prophylaxis: The Department of Defense (DoD) is proactively addressing this threat through its procurement of a naloxone auto-injector, explicitly indicated for temporary prophylaxis against high-potency opioids for military personnel and chemical incident responders operating under their authority.
Civilian Preparedness and Response: SNS, managed by the Administration for Strategic Preparedness and Response (ASPR), a part of Department of Health and Human Services (HHS). ASPR maintains over 1974 containers in 1330 locations throughout the USA, to ensure timely availability of antidotes to chemicals of concern to civilian population.
TH104 as a Promising Solution: Tharimmune's TH104, with its buccal film delivery and potential for a longer duration of action compared to existing naloxone formulations, offers a promising investigational countermeasure tailored to the demanding operational environments faced by military and civilian responders. Compared with current administration modes (intramuscular injections), the buccal administration route is potentially advantageous when personnel are wearing full protective gear.
"The positive feedback from the FDA on the NDA pathway for TH104 is a crucial step forward in addressing a critical national security concern - the potential weaponization of fentanyl and its derivatives," said Randy Milby, CEO of Tharimmune. "The market assessment clearly articulates the need for more options as effective prophylactic solutions for those on the front lines. TH104's novel formulation and pharmacokinetic profile could provide a significant advantage in protecting military personnel and chemical incident responders from the immediate and life-threatening effects of opioid exposure in contaminated environments."
The development of TH104 aligns directly with the U.S. government's increasing focus on preparedness against chemical threats, particularly those involving highly potent opioids. The positive FDA feedback provides a clear impetus for Tharimmune to continue its development program and work towards making this potentially life-saving prophylactic available to those who need it most.
About Tharimmune, Inc.
Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform targeting unique epitopes against multiple solid tumors through its proprietary EpiClick™Technology. The Company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. For more information, please visit: www.tharimmune.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.
Contacts
Tharimmune, Inc.
ir@tharimmune.com
Alliance Advisors IR
Tirth T. Patel
tpatel@allianceadvisors.com
212-201-6614
SOURCE: Tharimmune Inc.
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FAQ
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