TAHO Pharmaceuticals Initiates Phase III Trial of Apixaban Oral Dissolving Film
Key Insights
TAHO Pharmaceuticals (search) has commenced a Phase III clinical trial in the U.S. for TAH3311, an oral dissolving film (ODF) formulation of apixaban.
The trial is a pivotal bioequivalence study comparing TAH3311 to the tablet formulation of apixaban and will enroll 60 subjects.
TAH3311 aims to address swallowing difficulties in elderly patients and stroke (search) survivors, enhancing adherence and reducing caregiver burden.
TAHO Pharmaceuticals (search) Ltd. has announced the initiation of a Phase III clinical trial in the United States 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 in the development of this novel drug delivery system.
The U.S. Food & Drug Administration (FDA) accepted TAHO’s proposal for a 505(b)(2) NDA submission in July 2023, based on a single pivotal bioequivalence study. This open-label, randomized, crossover trial will enroll 60 subjects to compare the plasma concentration of TAH3311 to the approved tablet formulation of apixaban.
Addressing Clinical Limitations of Apixaban Tablets
Apixaban, co-developed by Bristol-Myers Squibb and Pfizer under the brand name Eliquis®, is a direct factor Xa (search) inhibitor widely used for stroke (search) prevention in non-valvular atrial fibrillation (search), thromboprophylaxis following hip or knee replacement surgery, and the treatment and prevention of deep vein thrombosis (search) and pulmonary embolism (search). Despite its efficacy and safety advantages as a leading novel oral anticoagulant (NOAC), apixaban is exclusively available in tablet form, which presents challenges for certain patient populations.
Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals (search), highlighted the difficulties faced by elderly patients, children, and stroke (search) survivors who have difficulty swallowing tablets. These patients often need to crush tablets, mix them with water, and administer them twice daily, which is a time-consuming and imprecise process that risks dosage loss. 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.
TAH3311: A Novel Approach to Anticoagulation
TAHO Pharmaceuticals (search) aims to leverage its proprietary Transepithelial Delivery System (TDS) to develop innovative dosage forms for niche markets. The TDS platform combines advanced transdermal and transmucosal delivery technologies, enabling the creation of unique dosage forms such as transdermal patches, ODF, and buccal films. TAH3311 represents a meaningful innovation in anticoagulant therapy by addressing the clinical limitations of the tablet form and capitalizing on the significant market potential of apixaban, which was the second-highest-selling drug globally in 2023.
TAHO Pharmaceuticals (search) has a diverse product portfolio spanning various therapeutic areas, including antithrombotic agents, opioid overdose antidotes, addiction treatments, pediatric ADHD, and chemotherapy-induced antiemetics. TAH4411, an ODF for chemotherapy-induced nausea and vomiting, was the first product of its kind to receive regulatory approval and be commercialized in Japan.