TAHO Pharma Initiates Phase III Trial of Apixaban Oral Dissolving Film
Key Insights
TAHO Pharma (search) has commenced a Phase III clinical trial in the US for TAH3311, an innovative oral dissolving film (ODF) formulation of the anticoagulant apixaban.
The trial is a pivotal bioequivalence study comparing TAH3311 to the tablet formulation of apixaban, aiming for a 505(b)(2) NDA submission to the FDA.
TAH3311 addresses swallowing difficulties faced by elderly patients and stroke (search) survivors, offering a convenient, water-free alternative to traditional tablets.
TAHO Pharmaceuticals Ltd. has announced the start of patient dosing in its US Phase III clinical trial for TAH3311, an innovative antithrombotic oral dissolving film (ODF) formulation of apixaban. This trial marks a significant step toward providing an alternative to traditional apixaban tablets, particularly for patients with swallowing difficulties.
The US Food and 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 Disadvantages of Existing Medications
According to Dr. Howard Lee, chairman and CEO of TAHO Pharmaceuticals, TAH3311 aims to address the clinical disadvantages of existing apixaban tablets. Apixaban, co-developed by BMS 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). It is a leading novel oral anticoagulant (NOAC) with notable safety advantages; however, it is exclusively available in tablet form.
Dr. Lee noted that the tablet form presents challenges for elderly patients, children, and stroke (search) survivors who have difficulty swallowing. These patients often need to crush tablets, mix them with water, and administer them twice daily, which is time-consuming, imprecise, and 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.
Market Potential and Innovation
Apixaban was the second-highest-selling drug globally in 2023, highlighting its significant market potential. By addressing the clinical limitations of the tablet form, TAHO Pharmaceuticals is positioning TAH3311 as a meaningful innovation in anticoagulant therapy.
TAHO Pharmaceuticals, founded in 2010, leverages its proprietary Transepithelial Delivery System (TDS) to overcome the limitations of existing drugs and develop innovative dosage forms for niche markets. The TDS platform combines advanced transdermal and transmucosal delivery technologies, enabling the development of unique dosage forms such as transdermal patches, ODF, and buccal films.