Tharimmune is seeking to develop TH104 for the proposed indication of “Temporary Prophylaxis of Respiratory and/or Nervous System Depression in Military Personnel and Chemical Incident Responders Entering and Area Contaminated with High-Potency Opioids”. Tharimmune recently received positive feedback from the U.S. Food and Drug Administration (FDA) regarding a regulatory pathway that will allow the Company to submit a 505(b)(2) New Drug Application (NDA) for TH104.
The FDA has confirmed that no additional clinical trials will be required prior to NDA submission for this indication.
The foundation for the FDA’s alignment on the submission of an NDA without additional clinical trials rests on the extensive existing data related to the approved active ingredient nalmefene embedded in TH104. This includes a comprehensive understanding of its safety profile, established through years of use in approved products, and evidence of its efficacy for opioid overdose.
Kappa-opiod receptors (KORs) and mu-opioid receptors (MORs) have been implicated in both the suppression and promotion of itch, respectively, and pronounced in conditions such as liver and atopic diseases.
