TAHO Pharmaceuticals has completed a bioequivalence trial comparing TAH3311, an oral dissolving film (ODF) apixaban formulation, to the agent's traditional tablet formulation. The trial enrolled 60 volunteers to evaluate the formulation, which is designed to be taken without water.

The study followed consultations with the U.S. Food and Drug Administration and the European Medicines Agency, proceeding under the 505(b)(2) regulatory pathway. TAH3311 is intended for use by patients with swallowing difficulties, including elderly patients, stroke survivors, and pediatric patients.

"The completion of this pivotal study is a significant step forward in TAHO's mission to bring [the] innovative Transepithelial Delivery System drug delivery solutions to patients worldwide," said Howard Lee, MD, 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."

According to IQVIA data, Apixaban (Eliquis) had U.S. sales of $22.1 billion in 2023, ranking it among the top-selling small-molecule medications globally. Apixaban is approved for multiple thromboembolic indications, including stroke risk reduction in nonvalvular atrial fibrillation, thromboprophylaxis following hip or knee replacement surgery, treatment of deep vein thrombosis or pulmonary embolism, and prevention of recurrent venous thromboembolism.

TAHO Pharmaceuticals plans to prepare regulatory submissions in the United States and Europe while pursuing strategic partnerships for global market access.

Reference:

TAHO Pharmaceuticals. TAHO Pharmaceuticals completes pivotal trial of TAH3311, the first oral dissolving film anticoagulant. PR Newswire. January 21, 2025. Accessed January 21, 2025. https://www.prnewswire.com/news-releases/taho-pharmaceuticals-completes-pivotal-trial-of-tah3311-the-first-oral-dissolving-film-anticoagulant-302355925.html