~ Global Phase 3 Trial Will Establish Therapeutic Equivalence Between TAVT-45 Granules for Oral Suspension and Zytiga® Tablets in Patients with Metastatic Castrate Sensitive Prostate Cancer (mCSPC) and Metastatic Castrate Resistant Prostate Cancer (mCRPC) ~
~ Potential to Become First FDA-Approved Granules for Oral Suspension Formulation of Abiraterone Acetate Which Reduces Pill Burden for Patients and is Administered at a Lower Dose Due to Increased Bioavailability ~
San Francisco, CA (UroToday.com) — Tavanta Therapeutics, a specialty pharmaceutical company, announced that the first patient has been dosed in a recently initiated global Phase 3 clinical trial evaluating TAVT-45 (abiraterone acetate) Granules for oral suspension (TAVT-45 granules), a novel and proprietary formulation of abiraterone acetate. In agreement with the U.S. Food and Drug Administration (FDA), the safety and efficacy of TAVT-45 Granules is being studied in a single Phase 3 trial as a treatment for metastatic castrate sensitive prostate cancer (mCSPC) and metastatic castrate resistant prostate cancer (mCRPC). TAVT-45 Granules was designed as an alternative for patients who have difficulty swallowing (dysphagia), which can be a side effect of some cancer treatments and occurs more frequently in elderly patients. TAVT-45 was also developed to address some of the limitations of current abiraterone treatment, including low bioavailability, high variability in systemic exposure, and large food effect.