#Taiwan #Taipei #TAHO Pharmaceuticals #TAH3311 #Apixaban

TAHO Pharmaceuticals Unveils Groundbreaking Anticoagulant Study Results

TAHO Pharmaceuticals, a leading innovator in pharmaceutical technologies, has marked a significant milestone with the announcement of positive preliminary results from the pivotal study of TAH3311, the world's first oral dissolving film (ODF) anticoagulant. This novel formulation serves as an innovative solution aimed at improving the quality of care for patients who struggle with traditional medications, particularly those with swallowing difficulties.

Study Details and Results

Conducted with 60 healthy volunteers, the pivotal study confirmed that TAH3311 is bioequivalent to established Apixaban tablets (marketed as Eliquis®) under fasting conditions. Notably, the pharmacokinetic parameters, including Cmax and AUC, fell well within the regulatory acceptance range of 80-125%. This achievement aligns with the expectations set by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), setting the stage for prospective New Drug Applications (NDA) and Marketing Authorization Applications (MAA).

Among the 60 participants, 48 successfully completed the trial, a testimony to the rigorous design of this study. The results yielded by TAHO mark a paradigm shift in anticoagulant delivery, fundamentally addressing the challenges faced by patients with difficulties swallowing medications.

Addressing Global Healthcare Needs

This advancement is especially critical given that an estimated 15 million people experience strokes globally each year. Around half of those admitted for strokes encounter issues with swallowing, making TAH3311's rapid dissolution a crucial feature. Traditional anticoagulants often entail cumbersome administration processes, necessitating crushing pills and mixing them with liquids, which can yield dosing inaccuracies and other complications.

Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals, emphasized the importance of this study, stating, "The pivotal study underscores our commitment to patient-centric innovation. TAH3311 is especially valuable for stroke patients, the elderly, and children who face challenges in swallowing. This novel formulation could dramatically improve outcomes and reduce the risk of aspiration pneumonia that is prevalent when medications are taken with water."

With U.S. sales of Apixaban reaching approximately $26.1 billion by 2024 and a continuously expanding global anticoagulant market, TAH3311 is positioned to redefine treatment accessibility and safety. TAHO Pharmaceuticals plans to submit regulatory filings in both the U.S. and Europe during the third quarter of 2025.

The Future of Anticoagulant Therapy

As part of its ongoing innovations, TAHO Pharmaceuticals is simultaneously pursuing strategic collaborations with international partners aimed at accelerating TAH3311's global launch. This strategic focus showcases the company’s dedication not only to advancing its product portfolio but also effectively addressing the nuanced needs of patients worldwide.

Insights on Apixaban

Apixaban is a direct factor Xa inhibitor, co-developed by Bristol-Myers Squibb and Pfizer, and has gained approval for a range of thromboembolic conditions, including stroke prevention in patients with non-valvular atrial fibrillation. The promising safety profile of Apixaban has solidified its place as a leading novel oral anticoagulant (NOAC) in the market.

About TAHO Pharmaceuticals

Founded in 2010, TAHO Pharmaceuticals is dedicated to addressing the limitations of existing pharmacological treatments through innovative dosage forms tailored for niche therapeutic markets. Utilizing its proprietary Transepithelial Delivery System (TDS), TAHO has established itself as a pioneer in developing diverse therapeutic options including transdermal patches and oral dissolving films. Their product lineup addresses critical areas such as antithrombotic agents and opioid overdose treatments, underscoring the company’s commitment to improving patient care.

For further details, visit TAHO Pharmaceuticals.

*Source: IQVIA 2024