Tharimmune Receives FDA Nod for TH104 NDA Pathway

Tharimmune, Inc., a biotechnology firm based in Bridgewater, NJ, announced positive feedback from the FDA on its plan to submit a New Drug Application for TH104. Utilizing the 505(b)(2) pathway, this application does not require additional clinical trials, thanks to existing pharmacokinetic data.

TH104, which incorporates nalmefene, aims to prevent respiratory and nervous system depression due to potent opioid exposure. This product also benefits from its buccal film formulation, offering rapid protection. Randy Milby, CEO, highlights the significance of these advancements in enhancing prophylactic measures for military personnel and responders.

The submission plan leverages prior data and sophisticated modeling to predict drug performance, focusing on Chemistry, Manufacturing, and Controls (CMC) to ensure product quality. Further updates from Tharimmune will be accessible through their investor relations page.