Tharimmune, Inc. announced on March 31, 2025, that it received positive feedback from the U.S. Food and Drug Administration (FDA) regarding a regulatory pathway for TH104. This feedback pertains to the proposed indication of temporary prophylaxis against respiratory and/or nervous system depression in military personnel and chemical incident responders exposed to high-potency opioids.
The FDA indicated that the company could pursue a 505(b)(2) New Drug Application (NDA) pathway for TH104. This pathway allows Tharimmune to leverage existing human pharmacokinetic data with TH104, potentially accelerating the development timeline.
Tharimmune is actively advancing its Chemistry, Manufacturing, and Controls (CMC) plan to meet the requirements for this NDA submission. This strategic pivot positions TH104 as a potential critical national security solution, with a potentially expedited path to market.
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