Tharimmune Reveals Promising PK Simulation Results for TH104

Tharimmune Inc., a biotechnology company, announced favorable pharmacokinetic simulation results for its leading clinical asset, TH104. TH104, a buccal film formulation of nalmefene, aims to serve as a prophylactic measure against respiratory depression from fentanyl and similar high-potency opioids. The company's simulation used data to demonstrate the efficacy of TH104 in maintaining protective nalmefene levels for up to 24 hours, a potential advantage over existing treatments like naloxone.

Fentanyl and related opioids signify national security threats due to their potency. The prolonged protection offered by TH104 is crucial in risky areas where quick medical intervention may not be possible. The non-injectable buccal film method allows for rapid absorption and ease of use, particularly beneficial for first responders in full protective gear. The FDA's positive feedback earlier this year implies no further trials are needed before a New Drug Application submission, paving the way for TH104's progression as a prophylactic option, especially in military settings.