TAHO Pharmaceuticals Ltd. has announced the commencement of its U.S. Phase III clinical trial for TAH3311, an innovative antithrombotic oral dissolving film (ODF) formulation of apixaban. The first subjects have been dosed in this pivotal study, marking a significant step toward a new formulation designed to improve patient adherence and ease of use.
Addressing Unmet Needs in Anticoagulation
Apixaban, co-developed by BMS and Pfizer under the brand name Eliquis®, is a direct factor Xa inhibitor widely used for reducing stroke risk in non-valvular atrial fibrillation and for the treatment and prevention of deep vein thrombosis and pulmonary embolism. Despite its efficacy, the existing tablet formulation poses challenges for specific patient populations, including the elderly, children, and stroke survivors who experience difficulty swallowing. These patients often require crushing the tablets, mixing them with water, and administering the medication twice daily, which can lead to dosage inaccuracies and increased caregiver burden.
TAH3311: A Novel Oral Dissolving Film
TAH3311 is designed to overcome these limitations by providing a quick-dissolving oral film that melts on the tongue, eliminating the need for water and reducing the risk of choking. This novel formulation aims to enhance patient adherence and simplify the administration process. According to Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals, "TAH3311 overcomes these barriers with a quick-dissolving oral film that melts on the tongue, requires no water, reduces the risk of choking, enhances patient adherence, and alleviates caregiver burden."
Phase III Trial Details
The Phase III trial is designed as a pivotal, open-label, randomized, crossover study involving 60 subjects. The primary objective is to demonstrate bioequivalence between TAH3311 and the approved tablet formulation of apixaban. The U.S. Food & Drug Administration (FDA) has accepted TAHO's proposal for a 505(b)(2) NDA submission based on this single pivotal bioequivalence study.
Apixaban: A Leading Anticoagulant
Apixaban is a leading novel oral anticoagulant (NOAC) known for its safety advantages. It is indicated for various thromboembolic disorders, including stroke risk reduction in non-valvular atrial fibrillation and thromboprophylaxis following hip or knee replacement surgery. In 2023, apixaban was the second-highest-selling drug globally, underscoring its importance in anticoagulant therapy.
TAHO Pharmaceuticals' Innovation
Founded in 2010, TAHO Pharmaceuticals leverages its proprietary Transepithelial Delivery System (TDS) to develop innovative dosage forms for niche markets. The TDS platform combines transdermal and transmucosal delivery technologies, enabling the creation of unique dosage forms such as transdermal patches, ODF, and buccal films. TAHO's portfolio includes products targeting antithrombotic agents, opioid overdose antidotes, addiction treatments, pediatric ADHD, and chemotherapy-induced antiemetics.
