TAHO Pharmaceuticals Ltd. has begun administering doses to participants in its phase III trial in the US for its leading product, TAH3311, a pioneering antithrombotic oral dissolving film (ODF). In July 2023, their proposal for a 505(b)(2) NDA submission, which featured a single pivotal bioequivalence study comparing the plasma concentration of TAH3311 to the existing tablet formulation, received approval from the US Food & Drug Administration (FDA). This essential, open-label, randomized, crossover trial plans to recruit 60 participants.
TAH3311 offers a cutting-edge ODF format of apixaban, known as a top-tier treatment for stroke prevention and thrombosis management.
Dr. Howard Lee, chairman and CEO of TAHO Pharmaceuticals, mentioned: “Our team is committed to creating new 505(b)(2) drug formulations that tackle the clinical shortcomings of current medications. The tablet form of apixaban often poses challenges for seniors, children, and stroke survivors with swallowing difficulties. These patients typically need to pulverize pills, mix them with water, and administer them twice a day—a cumbersome and imprecise procedure that could lead to dosing errors. TAH3311 addresses these obstacles with a rapidly dissolving oral film that melts on the tongue, eliminating the need for water, minimizing choking risks, boosting patient compliance, and reducing caregiver load.”
TAHO Pharmaceuticals is championing TAH3311 as a significant advance in anticoagulant therapy by overcoming the tablet’s clinical limitations and leveraging the vast market potential of apixaban.
Apixaban (developed collaboratively by BMS and Pfizer under the trade name Eliquis) serves as a direct Factor Xa inhibitor and is approved for several thromboembolic conditions, such as reducing stroke risk in non-valvular atrial fibrillation, thromboprophylaxis following joint surgeries, the treatment of deep vein thrombosis or pulmonary embolism, and prevention of recurrent cases. It is hailed as the leading novel oral anticoagulant (NOAC) on account of its safety profile. Various industry reports indicate that apixaban was among the top-selling drugs globally in 2023.
Established in 2010, TAHO Pharmaceuticals Ltd. utilizes its proprietary Transepithelial Delivery System (TDS) to remedy existing drug limitations and innovate dosage forms for specialized markets. The TDS platform integrates advanced transdermal and transmucosal delivery technologies, enabling the creation of unique dosage forms like transdermal patches, ODFs, and buccal films.