Salix Pharmaceuticals (NASDAQ:SLXP) believes that there’s enough solid data available now to warrant U.S. Food and Drug Administration approval of its new irritable bowel syndrome drug and at a meeting with the agency next month, the company will ask regulators to approve it.
If the FDA wants more work done on the drug, Salix CEO Carolyn Logan said that that work can be accomplished in post-marketing studies.
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Executives for Morrisville, North Carolina-based Salix described the plan to analysts during a conference call to discuss first-quarter earnings. Salix has been studying Xifaxan as a new IBS treatment and had expected FDA approval in March. Instead, the company received a complete response letter stating that the FDA could not approve the drug for that indication without more information about patient re-treatment.
William Forbes, Salix’ executive vice president for R&D and chief development officer, said that the FDA’s questions about re-treatment are about how patients who receive Xifaxan more than once will respond to future use of the drug.
Xifaxan is an antibiotic with a broad spectrum of activity against a variety of pathogens. The drug already has FDA approval for treating traveler’s diarrhea as well as hepatic encephalopathy, a brain disorder associated with severe liver disease. Salix has been trying to add irritable bowel syndrome as a new indication for the drug.
Failure to win approval for IBS has not hurt Salix’ financial performance. The company reported first-quarter revenue of $105.8 million, up 140 percent from $44.0 million a year ago. Xifaxan sales in the first quarter totaled $80.7 million, up 170 percent from $29.9 million a year ago. Salix also swung to a profit of $278,000 compared to a loss of $25.2 million in the first quarter of 2010.
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Forbes said that since the FDA’s March response letter rejecting Xifaxan for IBS, new data has been compiled about the drug. He pointed to a research study expected to be published soon showing that Xifaxan still shows efficacy in patients who are re-treated with the drug.
“The data makes us feel better and it’s powerful,” Forbes said.
Analysts asked executives if they thought the FDA would be receptive to the company’s plan. Logan said that although the company is confident in the data about Xifaxan, it’s hard to predict how the FDA will respond.
Salix’ meeting with the FDA is scheduled for June 20.
