TAIPEI, Jan. 21, 2025 /PRNewswire/ -- TAHO Pharmaceuticals is pleased to announce the successful completion of the pivotal trial for TAH3311, the first anticoagulant oral dissolving film (ODF). This trial was conducted following detailed discussions and alignment with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), marking a major milestone in the advancement of this innovative product under the 505(b)(2) regulatory pathway.
The trial enrolled 60 healthy volunteers to compare TAH3311 ODF with the Apixaban tablet (brand name Eliquis®) under the bioequivalence (BE) regulatory framework. Apixaban, a Factor Xa inhibitor, is widely used for stroke prevention and treatment of thromboembolic conditions due to its lower dosage requirements and reduced gastrointestinal bleeding risk compared to other anticoagulants. TAH3311 addresses a significant unmet need in this market by offering the first ODF formulation, providing a water-free alternative that is especially beneficial for patients with swallowing difficulties, including the elderly, stroke survivors, and children.
According to IQVIA, the global market for anticoagulants is rapidly expanding, with apixaban achieving U.S. sales of $22.1 billion in 2023, making it the leading small-molecule drug globally and the second best-selling drug overall.* This remarkable growth highlights a significant opportunity for TAH3311 to address existing clinical unmet needs while offering a unique differentiation in an increasingly competitive landscape.
With the trial's completion, TAHO Pharmaceuticals plans to prepare regulatory submissions in both the United States and Europe. Simultaneously, the company is actively pursuing strategic collaborations with international partners to accelerate the global launch of TAH3311 and maximize its impact in key markets.
"The completion of this pivotal study is a significant step forward in TAHO's mission to bring innovative Transepithelial Delivery System (TDS) drug delivery solutions to patients worldwide," said Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals. "As the first ODF formulation in the anticoagulant space, TAH3311 has the potential to transform how these life-saving therapies are delivered, especially for patients who face difficulties with traditional tablet forms."
*Source: www.pharmacompass.com
About Apixaban
Apixaban (co-developed by BMS and Pfizer under the brand name Eliquis®) is a direct factor Xa inhibitor and has been approved for clinical use in several thromboembolic disorders, including reduction of stroke risk in non-valvular atrial fibrillation, thromboprophylaxis following hip or knee replacement surgery, the treatment of deep vein thrombosis or pulmonary embolism, and prevention of recurrent deep vein thrombosis and pulmonary embolism. With notable safety advantages, it is the leading novel oral anticoagulant (NOAC). According to various industry reports, apixaban was the second-highest-selling drug globally in 2023.
About TAHO Pharmaceuticals Ltd.
Founded in 2010, TAHO Pharmaceuticals Ltd. 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. TAHO's diverse product portfolio spans a variety of therapeutic areas, including antithrombotic agents, opioid overdose antidotes, addiction treatments, pediatric ADHD, and chemotherapy-induced antiemetics. Among its notable achievements, TAH4411, an ODF for chemotherapy-induced nausea and vomiting, became the first product of its kind to receive regulatory approval and be commercialized in Japan.