TAHO Pharmaceuticals has announced the commencement of its Phase III clinical trial in the United States for TAH3311, an innovative oral dissolving film (ODF) formulation of apixaban. The trial marks a significant step toward providing an alternative to traditional tablet formulations, particularly beneficial for patients with swallowing difficulties.
The U.S. 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 Challenges with ODF Technology
Apixaban, co-developed by BMS and Pfizer under the brand name Eliquis®, is a direct factor Xa inhibitor widely used as a first-line treatment for stroke prevention and thrombosis management. However, its exclusive availability in tablet form poses challenges for specific patient populations.
"Apixaban, available exclusively in tablet form, often presents challenges for elderly patients, children, and stroke survivors who have difficulty swallowing," said Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals. "These patients frequently need to crush tablets, mix them with water, and administer them twice daily—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."
Potential Impact on Anticoagulant Therapy
TAH3311 aims to improve patient adherence and simplify drug administration by delivering apixaban in an ODF that dissolves rapidly on the tongue. This eliminates the need for water and reduces the risk of choking, making it a more convenient option for patients with swallowing difficulties. Apixaban is a leading novel oral anticoagulant (NOAC) with notable safety advantages and was the second-highest-selling drug globally in 2023.
About TAHO Pharmaceuticals
Founded in 2010, TAHO Pharmaceuticals leverages its proprietary Transepithelial Delivery System (TDS) to develop innovative dosage forms for niche markets. Their 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 product portfolio spans 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 of its kind to receive regulatory approval and be commercialized in Japan.
