BEKINDA® (formerly RHB-102) is a proprietary, oral, extended-release (24 hours), once-daily pill formulation of the antiemetic drug ondansetron.
RedHill is developing BEKINDA® for the prevention of Nausea and vomiting in patients undergoing cancer chemotherapy or radiotherapy.
BEKINDA® is currently the only once-daily oral formulation of ondansetron. It presents significant potential advantages for cancer patients over the immediate release oral ondansetron tablets currently on the market. The once-daily oral formulation of BEKINDA® could significantly improve patient compliance, thus improving the ability to withstand treatment and, as a result, potentially increasing patient adherence to chemotherapy and radiotherapy.
A European marketing application (MAA) for the indications of chemotherapy and radiotherapy-induced nausea and vomiting was submitted to the UK MHRA Dec. 2014 and withdrawn - RedHill is currently in discussions with EU Member States.
The MAA is supported by a number of pharmacokinetic studies comparing BEKINDA® to several approved regimens of Zofran®, including a comparative bioavailability study with the European reference drug, Zofran® suppositories.
A potential path for U.S. NDA submmision is subject to data from ongoing and planned efficacy studies with BEKINDA®.