APD403
Chemotherapy-induced nausea & vomiting (CINV)
APD403 is based on the selective dopamine antagonist amisulpride, the same active ingredient as in Barhemsys®. It is being developed as an intravenous injection for cancer patients to be administered immediately before they receive chemotherapy to prevent acute CINV, and as an oral tablet to prevent delayed CINV.
The efficacy and safety of Byfavo® have been investigated as part of an extensive clinical trial program involving approximately 2,400 volunteers and patients. Byfavo® was approved in the UK in July 2020.
APD403 has successfully completed one proof-of-concept and one Phase 2 dose-ranging study demonstrating it is well tolerated and effective at preventing acute and delayed CINV. Covance Laboratories intends to advance APD403 into Phase 3 studies following completion of a further Phase 2 study.