Salix Pharmaceuticals discusses proposed rifaximin NDA with the FDA

Dec 10 2009

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today reported that the Company held a pre-NDA meeting on December 8, 2009 with the FDA to discuss the Company’s proposed new drug application (NDA) for rifaximin in the treatment of patients with non-constipation irritable bowel syndrome (non-C IBS). The purpose of the meeting was to discuss the completion of the Company’s non-C IBS Development Program, the results of two Phase 3 trials, TARGET 1 and TARGET 2, and to reach agreement on the content and format of the Company’s pending NDA.

“We are pleased with the results of our discussions with the FDA regarding our completed Phase 3 trials and our proposed NDA for rifaximin in the treatment of non-C IBS,” stated Bill Forbes, Pharm.D., Senior Vice President Research and Development and Chief Development Officer, Salix. “During our meeting, we were able to review the prior agreements reached with the Gastrointestinal Division. As expected, the agreements, including the protocol-specified primary and key secondary endpoints used in TARGET 1 and TARGET 2 as the basis of the review for marketing approval of rifaximin in non-C IBS, were confirmed. It has been known that the FDA’s Division of Gastroenterology Products (DGP), along with assistance from the Study Endpoint and Labeling Development (SEALD) Team, have been developing a new guidance for the use of endpoints in IBS clinical trials. The Phase 3 trials were designed, in consultation with the Division, to investigate the utility of rifaximin in non-C IBS by assessing adequate relief of IBS symptoms, adequate relief of IBS-related bloating and other endpoints such as abdominal pain and stool consistency. We are pleased that a clear regulatory pathway for the review and potential approval of rifaximin in non-C IBS has been provided. We continue to target submission of the NDA during the first half of 2010.”