RedHill Reports Positive Pharmacokinetic Studies For RHB-102

(RTTNews) - RedHill Biopharma Ltd. (RDHL), Tuesday reported positive results from two supplementary pharmacokinetic studies with RHB-102, an anti-emetic oncology-support drug. The final independent report from the Canadian clinical research organization is expected in the coming weeks. RHB-102 is an oral formulation of ondansetron, the active ingredient in GlaxoSmithKline's Zofran immediate release tablets for the prevention of radiotherapy induced nausea and vomiting and chemotherapy induced nausea and vomiting.

The first study assessed the effect of food on the bioavailability of RHB-102, and the study was a multiple day dosing comparative bioavailability study with Zofran immediate release tablets as the reference drug.

The studies were initiated by the company in July, to support the planned submission of a New Drug Application. Subject to the results of the pre-NDA meeting, completion of Chemistry, Manufacturing and Control modules, and the required regulatory process, the Company plans to submit an NDA for RHB-102 in the first quarter of 2014, seeking U.S. marketing approval.