Tharimmune Inc., a clinical-stage biotechnology company, has announced positive results from a pharmacokinetic simulation analysis of its lead clinical asset, TH104. This buccal film formulation of nalmefene is being developed as a prophylactic countermeasure against respiratory depression from high-potency opioids such as weaponized fentanyl. The analysis, based on data from literature and Tharimmune's Phase 1 study, demonstrated that TH104 can achieve protective concentrations against fentanyl-induced respiratory depression within approximately 30 minutes post-dose, maintaining this protection for about 24 hours. This result highlights the potential superiority of TH104 over existing treatments, like naloxone injection products, which have a shorter duration of effect. The findings underscore TH104's potential in providing sustained protection in high-risk environments where exposure to potent opioids is a constant threat.
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