RHB-102 is a once daily controlled release proprietary formulation of ondansetron. Ondansetron is marketed under various trade names including GSK’s Zofran®. RHB-102 was licensed from SCOLR Pharma, Inc. [Amex: DDD] in May 2010. As Zofran, RHB-102 is a 5-HT3 receptor antagonist and is planned to be indicated for prevention of nausea and vomiting for cancer patients. Two clinical PK studies were conducted.
After obtaining both an IND (Investigational New Drug Application) approval from the FDA and a CTA (Clinical Trial Application) approval from the Canadian Health Authority, In April 2012, RedHill announced positive results in a pivotal bioequivalence clinical trial with RHB-102 and is planning to file an NDA with the U.S. FDA in Q1-Q2/2014.