Taiwan-based TAHO Pharmaceuticals announced positive preliminary results from a pivotal study for its TAH3311 oral dissolving films, a generic version of Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban). The study demonstrated that TAH3311 was bioequivalent to the reference drug under fasting conditions.
Study Results
The trial involved 60 healthy subjects, with 48 completing the experiment. Results showed that TAH3311 achieved Cmax (peak concentration) and AUC (area under the curve) values within the regulatory range of 80% to 125%, aligning with standards discussed with the US FDA and European EMA.
Drug Profile
Apixaban is a highly selective, reversible, direct factor Xa inhibitor approved for multiple thromboembolic diseases, including stroke prevention in non-valvular atrial fibrillation, thrombosis prevention after hip/knee replacement surgery, and treatment of deep vein thrombosis or pulmonary embolism.
Company Background
Founded in 2010, TAHO Pharmaceuticals specializes in a transdermal delivery system (TDS) integrating advanced transdermal and mucosal drug delivery technologies. The company develops unique dosage forms such as transdermal absorption patches, oral dissolving films, and buccal dissolving films.-Fineline Info & Tech
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