Red Hill to proceed with Phase 3 trial

|By:, SA News Editor

The FDA clears Red Hill Biopharma's (RDHL) IND amendment allowing it to initiate a Phase 3 clinical trial for a new indication of RHB-102, a once-daily extended release oral formulation of the antiemetic drug ondansetron. Patient enrollment for the 320-subject eight-site U.S. trial will be begin in Q3.

In parallel, the company is pursuing marketing approval for the use of RHB-102 for chemotherapy and radiotherapy-induced nausea and vomiting in the U.S. and Europe.