TAHO Pharmaceuticals' TAH3311 Oral Film Shows Bioequivalence to Apixaban in Pivotal Trial
核心洞察
Taho Pharmaceuticals (搜索)' TAH3311, an apixaban oral dissolving film (ODF), demonstrated bioequivalence to Eliquis® tablets in a pivotal study.
The trial enrolled 60 healthy volunteers and met criteria agreed upon with the FDA and EMA for regulatory submissions.
TAH3311 offers a more convenient, water-free alternative for patients with swallowing difficulties, such as stroke (搜索) patients.
TAHO Pharmaceuticals (搜索) has announced positive results from its pivotal study of TAH3311, an oral dissolving film (ODF) formulation of apixaban. The study demonstrated that TAH3311 is bioequivalent to the reference apixaban tablets (Eliquis®) under fasting conditions, with Cmax and AUC values falling within the regulatory acceptance range of 80-125%. This innovative formulation aims to address the unmet needs of patients with swallowing difficulties, offering a more convenient and safer alternative to traditional tablets.
The pivotal trial enrolled 60 healthy volunteers, with 48 completing the study. The results have been discussed with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and meet the criteria for filing a New Drug Application (NDA) and a Marketing Authorization Application (MAA), respectively.
Addressing Dysphagia in Anticoagulation
Globally, stroke (搜索) affects millions, with a significant portion experiencing dysphagia, or swallowing difficulties. According to the World Stroke Organization (WSO), more than 12.2 million new strokes occur each year. Nearly half of hospitalized stroke patients experience swallowing difficulties, and approximately 13% develop long-term dysphagia. Conventional anticoagulants often require crushing tablets and mixing with liquids, which can lead to dosing inaccuracies and increase the risk of aspiration pneumonia.
TAH3311 dissolves rapidly in the mouth without water, offering a practical solution for patients who struggle with traditional tablets. "This pivotal study underscores our commitment to patient-centric innovation," said Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals (搜索). "TAH3311 is especially valuable for stroke (搜索) patients, the elderly, children or others who have swallowing difficulties and require anticoagulant therapy twice daily. We believe this novel formulation can improve patient outcomes and reduce the risk of aspiration pneumonia caused by choking when swallowing medication with water."
Regulatory and Commercial Strategy
TAHO Pharmaceuticals (搜索) plans to file regulatory submissions in both the United States and Europe in Q3 2025. The company is also actively seeking strategic collaborations with international partners to accelerate the global launch of TAH3311.
Apixaban, co-developed by BMS and Pfizer under the brand name Eliquis®, is a direct factor Xa (搜索) inhibitor used to prevent stroke (搜索) in non-valvular atrial fibrillation (搜索), for thromboprophylaxis after hip/knee replacement, and for treating and preventing deep vein thrombosis (搜索) or pulmonary embolism (搜索). With notable safety advantages, it is the leading novel oral anticoagulant (NOAC).
About TAHO Pharmaceuticals
Founded in 2010, TAHO Pharmaceuticals (搜索) 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 development of products like transdermal patches, ODFs, and buccal films. TAHO's 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 be approved and commercialized in Japan.