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news.Salix Pharmaceuticals, a company that develops and markets prescription pharmaceutical products, has received marketing approval from the FDA for Xifaxan (rifaximin) 550mg tablets, for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years of age or older.
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Salix Pharma said that FDA approval of Xifaxan 550mg tablets was based on a 299 subject, double-blind, placebo-controlled, multinational, Phase 3 clinical trial. Trial results demonstrated a positive and clinically meaningful reduction in the risk of overt HE recurrence.
The primary endpoint of the trial was the risk of experiencing a breakthrough overt HE episode, was reduced by 58% in Xifaxan 550mg-treated subjects compared with placebo. The key secondary endpoint, risk of experiencing HE-related hospitalisation was reduced by 50% in Xifaxan 550mg-treated subjects compared with placebo.
Salix anticipates Xifaxan 550mg tablets to be available for physicians and patients by the end of May 2010. In preparation for the launch, it is targeting to begin shipping product to wholesalers in early May and to complete the training of its 160-member sales force during the week of May 17.
Reportedly, Xifaxan has been granted orphan drug designation by the FDA for use in hepatic encephalopathy. With Xifaxan 550mg tablets now approved by the FDA, Salix believes this designation should provide seven years of marketing exclusivity in the US.
Bill Forbes, executive vice president of research and development and chief development officer at Salix Pharmaceuticals, said: “The imminent availability of Xifaxan 550mg tablets signals an important advancement for overt HE patients, their caregivers and the health care community supporting these patients.
“An episode of overt HE can result in a patient losing cognitive function or even death. These symptoms, in a number of incidences, necessitate a clinic or emergency room visit or hospital admission. We are pleased to bring Xifaxan 550 mg tablets to market and believe the utilisation of this treatment should serve to reduce the recurrence of overt HE as well as the number of hospitalisations associated with this serious condition.”