Taho Pharmaceuticals has announced the completion of the pivotal trial for TAH3311, an anticoagulant oral dissolving film (ODF).
The trial was conducted following detailed discussions and alignment with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), marking a major milestone in the advancement of this innovative product under the 505(b)(2) regulatory pathway, the company says in a press release.
The trial enrolled 60 healthy volunteers to compare TAH3311 ODF with the Apixaban tablet under the bioequivalence (BE) regulatory framework. Apixaban, a Factor Xa inhibitor, is widely used for stroke prevention and treatment of thromboembolic conditions due to its lower dosage requirements and reduced gastrointestinal bleeding risk compared to other anticoagulants.
TAH3311 addresses a significant unmet need in this market by offering the first ODF formulation, providing a water-free alternative that is especially beneficial for patients with swallowing difficulties, including the elderly, stroke survivors, and children, Taho Pharmaceuticals says in a press release.
With the trial’s completion, Taho Pharmaceuticals plans to prepare regulatory submissions in both the USA and Europe. Simultaneously, the company is pursuing strategic collaborations with international partners to accelerate the global launch of TAH3311 and maximise its impact in key markets.
“The completion of this pivotal study is a significant step forward in Taho’s mission to bring innovative transepithelial delivery system (TDS) drug delivery solutions to patients worldwide,” said Howard Lee, chairman and CEO of Taho Pharmaceuticals. “As the first ODF formulation in the anticoagulant space, TAH3311 has the potential to transform how these life-saving therapies are delivered, especially for patients who face difficulties with traditional tablet forms.”
