Breaking News: Tharimmune Receives Encouraging FDA Response on NDA Journey for TH104 in Preventing R-Related Illness
Description:
Tharimmune, Inc. (Nasdaq:THAR), a clinical-stage biotechnology company specializing in immunology and inflammation, has received positive feedback on its New Drug Application (NDA) submission for TH104 via the 505(b)(2) pathway. The company is leveraging existing human pharmacokinetic data with TH104 and is advancing its Chemistry, Manufacturing, and Controls (CMC) plan to meet the requirements of the NDA.
In addition to developing TH104 for the treatment of moderate-to-severe chronic pruritus in patients with primary biliary cholangitis using an approved active ingredient now in buccal film form, Tharimmune is also seeking to develop TH104 for the temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders entering areas contaminated with high-potency opioids. The company has submitted a Pre-Investigational New Drug Application (PIND) for this additional proposed indication.
Impact on Me:
The positive feedback from the FDA regarding Tharimmune’s regulatory pathway for TH104 signifies potential progress in developing a new drug that could prevent respiratory and nervous system depression in individuals exposed to high-potency opioids. If approved, this development could create new treatment options for individuals working in high-risk environments.
Impact on the World:
Tharimmune’s progress in developing TH104 for multiple indications, including the temporary prophylaxis of respiratory and nervous system depression in high-risk situations, has the potential to significantly impact public health and safety globally. The availability of a new drug to prevent illness and injury in individuals facing opioid contamination could contribute to emergency response preparedness and help protect the well-being of military personnel and chemical incident responders worldwide.
Conclusion:
Tharimmune’s promising journey with TH104 and the encouraging FDA response on the NDA submission for preventing R-related illness represents a significant step forward in biotechnology and pharmaceutical innovation. The company’s commitment to developing new treatments that address critical health concerns demonstrates a dedication to improving patient outcomes and public health on a global scale.
