RED BANK, NJ — August 20, 2025 — Leads & Copy — Tharimmune, Inc. (Nasdaq:THAR) announced positive results from a pharmacokinetic (PK) simulation analysis of TH104, a buccal film formulation of nalmefene. The results reinforce the potential of TH104 as a prophylactic countermeasure for military personnel and chemical incident responders who may be exposed to high-potency opioids, including weaponized fentanyl and its analogues.
The analysis used pharmacokinetic simulations of TH104 as prophylaxis for respiratory depression in exposure to synthetic opioids based on data from the literature. A threshold effect, (i.e. the protection from respiratory depression) was found to be achieved in approximately 30 minutes post dose and shown to maintain above this protection for about 24 hours. The buccal film delivery of TH104 is designed as a non-injectable, rapid absorption and convenient-to-use administration, which may be advantageous for first responders who may be wearing full protective gear.
Positive feedback earlier this year from the U.S. Food and Drug Administration (FDA) confirmed that no additional clinical trials appear necessary prior to a 505(b)(2) New Drug Application (NDA) submission.
For more information, contact ir@tharimmune.com
Source: Tharimmune, Inc.
