Tharimmune announces FDA feedback on TH104 for prophylaxis

Tharimmune (THAR) announced feedback from the U.S. Food and Drug Administration regarding TH104. The agency confirmed that no additional clinical trials appear to be necessary prior to a 505(b)(2) New Drug Application 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. 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: The Department of Defense 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. SNS, managed by the Administration for Strategic Preparedness and Response, a part of Department of Health and Human Services. ASPR maintains over 1974 containers in 1330 locations throughout the USA, to ensure timely availability of antidotes to chemicals of concern to civilian population. 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, the buccal administration route is potentially advantageous when personnel are wearing full protective gear.