RedHill Biopharma, an emerging Israeli biopharmaceutical company focussed primarily on the development and acquisition of late clinical-stage proprietary drugs for the treatment of inflammatory and gastrointestinal diseases and related conditions, announced that the US Food and Drug Administration (US FDA) has allowed the initiation of the company's planned phase III clinical study for the treatment of a new, undisclosed indication with RHB-102, an extended release oral pill formulation of the antiemetic drug ondansetron. RedHill plans to begin enrolling patients for the phase III study during the third quarter of 2014.

The double-blind placebo-controlled phase III study is planned to be conducted in eight clinical sites in the US. and will include 320 subjects. Based on prior discussions with the FDA and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the study is intended to support potential future submissions of marketing applications for a new undisclosed indication in both the US and Europe. RedHill estimates that, if the phase III clinical study is successful and the marketing applications are filed and approved by the FDA and the MHRA, the new indication would significantly expand the potential market for RHB-102.

In parallel to pursuing the new undisclosed indication, RedHill is pursuing marketing approval of RHB-102 for the indications of chemotherapy and radiotherapy-induced nausea and vomiting ("CINV" and "RINV" respectively) in Europe and the US.  

Following a European scientific advice meeting with the UK’s MHRA, RedHill recently reported positive results from a comparative bioavailability study comparing RHB-102 and a European reference drug. In light of the positive results from the bioavailability study and data from prior successful clinical studies, and subject to various regulatory requirements, RedHill plans to submit a European Marketing Authorisation Application (MAA) for RHB-102 during the third quarter of 2014 for the indications of CINV and RINV prevention.

Additionally, RedHill announced in March 2014 that it had held a pre-New Drug Application (pre-NDA) meeting with the FDA regarding the development of RHB-102 for CINV and RINV prevention in the US. Following the pre-NDA meeting, and in light of the FDA's feedback, RedHill provided the FDA with additional information and is currently awaiting the FDA's response.