RALEIGH, N.C., Aug 08, 2011 (BUSINESS WIRE)
"We are pleased to announce that the Company has determined to continue the development of XIFAXAN 550 for the treatment of IBS. On June 20, 2011 the Company held an End of Review Conference with the U.S. Food and Drug Administration (FDA) regarding our supplemental New Drug Application (sNDA) for XIFAXANŽ (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating. At the meeting and during conversations held subsequent to the meeting, the FDA communicated its intention to work with Salix in an open, collaborative way regarding the development of rifaximin in IBS. At the center of these discussions has been the issue of determining what information will be needed for a substantive response to the Complete Response Letter issued by the FDA in March of this year. Since IBS is a serious and unmet medical condition, the FDA has proposed, and Salix has agreed, to convene an Advisory Committee. The purpose of the Advisory Committee is to review the rifaximin IBS data with a focus on the design of the clinical study for the retreatment of patients. The tentative date for this Advisory Committee is November of this year. Currently the Company is continuing its discussions with the FDA, key opinion leaders and various regulatory consultants. The intention is to utilize the input gained from these discussions as well as from the Ad Com to finalize a development plan going forward for a retreatment study. At this time we are targeting to initiate patient enrollment into a retreatment trial by the end of the year 2011 or early 2012. Currently we anticipate that approximately 24 months could be required to complete the trial and secure an FDA decision regarding approval."
Cheers.
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ibs-d (pseudo)with pain and bloating
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Salix determined to continue the development of XIFAXAN 550 for the treatment of IBS
