Tharimmune Announces Positive FDA
Tharimmune received positive FDA feedback regarding the development of TH104, a buccal film formulation containing nalmefene, for prophylaxis against ultrapotent opioid exposure. The FDA confirmed that no additional clinical trials will be required for the New Drug Application (NDA) submission via the 505(b)(2) pathway.
The company is developing TH104 for two indications:
· Moderate-to-severe chronic pruritus in patients with primary biliary cholangitis (PBC).
· Temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders exposed to high-potency opioids.
The FDA's decision is based on existing safety and efficacy data of nalmefene, combined with Tharimmune's pharmacokinetic data. The company will use 'in silico' computer simulations to predict TH104's effectiveness as prophylaxis. Tharimmune is also advancing its Chemistry, Manufacturing, and Controls (CMC) plan to meet NDA requirements.
Tharimmune's receipt of positive FDA feedback for their TH104 drug represents a significant regulatory win. The FDA's confirmation that no additional clinical trials will be required for the 505(b)(2) New Drug Application pathway is particularly valuable for several reasons.
The 505(b)(2) pathway allows Tharimmune to leverage existing data for nalmefene (the active ingredient), substantially reducing both the time and cost to potential approval. This approach is especially powerful as it enables the company to utilize an established drug while providing a novel delivery mechanism (buccal film) for a new indication.
What makes this regulatory strategy particularly clever is Tharimmune's use of pharmacokinetic data and "in silico" modeling (computer simulation) to support their application. Rather than conducting extensive new human trials, they can demonstrate efficacy through mathematical models that predict how TH104 will perform as prophylaxis against opioid exposure.
This development pathway significantly de-risks the regulatory process for their second indication targeting military personnel and chemical incident responders. Moving forward with their Chemistry, Manufacturing, and Controls plan represents the next critical step, focusing on consistency in manufacturing their buccal film formulation to FDA standards.
