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 Clinical Disadvantages of Existing Medications
The trial is based on the U.S. Food & Drug Administration (FDA) acceptance of TAHO's proposal for a 505(b)(2) NDA submission in July 2023. The study is designed as a pivotal, open-label, randomized, crossover trial involving 60 subjects. It will compare the plasma concentration of TAH3311 to the approved tablet formulation of apixaban to establish bioequivalence.
Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals, emphasized the company's commitment to addressing the clinical disadvantages of existing medications through innovative formulations. "Apixaban, available exclusively in tablet form, often presents challenges for elderly patients, children, and stroke survivors who have difficulty swallowing," Dr. Lee noted. These patients often require crushing tablets and mixing them with water, a process that is both time-consuming and imprecise, potentially leading to dosage inaccuracies.
Overcoming Barriers with Oral Dissolving Film
TAH3311 is designed to overcome these barriers with a quick-dissolving oral film that melts on the tongue, eliminating the need for water and reducing the risk of choking. This innovative formulation aims to enhance patient adherence and alleviate caregiver burden, offering a more convenient and reliable method of drug administration.
About Apixaban
Apixaban, co-developed by Bristol-Myers Squibb (BMS) and Pfizer under the brand name Eliquis®, is a direct factor Xa inhibitor widely used for the reduction of stroke risk in non-valvular atrial fibrillation, thromboprophylaxis following hip or knee replacement surgery, and the treatment and prevention of deep vein thrombosis and pulmonary embolism. As a leading novel oral anticoagulant (NOAC), apixaban offers notable safety advantages and was the second-highest-selling drug globally in 2023.
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 advanced transdermal and transmucosal delivery technologies, enabling the creation of unique dosage forms such as transdermal patches, ODF, and buccal films. TAHO's diverse product portfolio includes antithrombotic agents, opioid overdose antidotes, addiction treatments, pediatric ADHD medications, 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.
