RedHill Biopharma Ltd. (Nasdaq: RDHL); TASE: RDHL) has reported positive results from two supplementary pharmacokinetic studies with RHB-102, an anti-emetic oncology-support drug. The company will use studies the support its planned New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first quarter of 2014.
Redhill develops proprietary formulations and combinations of existing drugs. RHB-102 is a patented extended-release (24 hours) oral formulation of ondansetron, the active ingredient in GlaxoSmithKline plc (NYSE; LSE: GSK) Zofran for the prevention of radiotherapy induced nausea and vomiting and chemotherapy induced nausea and vomiting.
The results of pharmacokinetic studies are subject to final analysis and an independent study report by the Canadian Clinical Research Organization, which conducted the studies. The final independent report is due in a few weeks.
RedHill is also developing RHB-103, an oral thin film formulation of rizatriptan, for the treatment of acute migraine. The company filed an NDA in June, and expects a response from the FDA in February 2014. The company has also begin a Phase III clinical trial of RHB-104 for the treatment of Crohn's disease and plans to commence a Phase II/III clinical trial of RHB-105 (H. pylori) this month.
Published by Globes [online], Israel business news - www.globes-online.com - on October 9, 2013
© Copyright of Globes Publisher Itonut (1983) Ltd. 2013