Tavanta Therapeutics, a Hungary-based clinical-stage specialty pharmaceutical company, announced on Monday that it has completed patient enrolment for its pivotal Phase three study of TAVT-45 (abiraterone acetate) Granules for Oral Suspension (TAVT-45), a novel oral suspension formulation of abiraterone acetate designed to address needs of metastatic prostate cancer patients who have difficulty swallowing (Dysphagia), an issue for 20 to 30% of prostate cancer patients.
TAVT45CO2 is a global Phase three clinical trial assessing the product in patients with metastatic castrate-sensitive prostate cancer (mCSPC) and metastatic castrate-resistant prostate cancer (mCRPC). The primary aim of the study is to set up therapeutic equivalence between TAVT-45 and Zytiga tablets.
Top-line results are likely to be revealed in the fourth quarter of 2022. The firm plans to submit a new drug application (NDA) to the United States Food & Drug Administration in the third quarter of 2023.
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