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. In March 2014 RedHill secured the direct rights to the original RHB-102 patents from Temple University, following SCOLR’s announcement that the they had ceased their business operations.
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. Following a Type B meeting held with the FDA in February 2013, RedHill announced in October 2013 that it had received positive results in two supplementary pharmacokinetic studies with RHB-102.
In March 2014 RedHill announced that it had held a pre-NDA meeting with the FDA, and is currently in discussions with the FDA regarding the submission of the U.S. NDA for RHB-102.
In April 2014 RedHill announced that it had concluded a positive European scientific advice meeting with the UK MHRA regarding RHB-102 and that it had received positive results from a comparative bioavailability study comparing RHB-102 to a European reference drug. In light of the positive feedback from the UK MHRA and the successful bioavailabiliy study , RedHill intends to submit, during the third quarter of 2014, a Marketing Authorization Application (MAA) in Europe.
In parallel to pursuing the current indications in the U.S. and Europe, RedHill is also pursuing a new undisclosed indication for RHB-102 and is planning to commence a Phase III clinical study for this indication during the third quarter of 2014.