Salix Pharmaceuticals (NASDAQ:SLXP) needs another clinical study on its irritable bowel syndrome treatment, which means it could take two more years for the drug to secure regulatory approval.
That’s two more years than the gastrointestinal therapeutics company planned for. Salix expected to get U.S. Food and Drug Administration approval for the drug Xifaxan in the first quarter. But in March, the FDA told Morrisville, North Carolina-based Salix that it would not approve Xifaxan for IBS.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
During a Monday conference call to discuss second-quarter financial results, Salix CEO Carolyn Logan said that the FDA proposed and the company agreed to form an advisory committee to review the Xifaxan IBS data. That committee will design a clinical study to get more information about IBS patients retreated with Xifaxan. Salix had earlier insisted that there was sufficient data available to warrant FDA approval and any additional work could be done in studies after the drug reaches the market. With Monday’s disclosure of a forthcoming clinical study, it now means that Salix will need to spend more time and money in order to get FDA approval.
The advisory committee is tentatively scheduled to meet in November. Patient enrollment for the new study is expected to start by the end of this year or in early 2012.
“Currently we anticipate that approximately 24 months could be required to complete the trial and secure an FDA decision regarding approval,” Logan said. That 24-month clock starts when the new trials start.
Xifaxan is an antibiotic that has shown activity against a variety of pathogens. The drug has already been approved for treating traveler’s diarrhea as well as hepatic encephalopathy, a rare brain disorder associated with severe liver disease. Salix had sought to add irritable bowel syndrome as a new indication for the drug, which is Salix’s top seller. Salix reported second-quarter revenue of $133.2 million, a 42 percent increase compared to the second quarter of 2010. Xifaxan sales totaled $87 million in the quarter, a 20 percent year-over-year increase. Salix’s net income was $19.2 million for the quarter. A year ago, Salix reported a $23.6 million loss.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
William Forbes, Salix’s executive vice president for R&D and chief development officer, said the FDA’s questions about Xifaxan’s use in IBS relate to retreatment. Forbes said that no safety concerns have arisen related to Xifaxan. Forbes declined to discuss specifics of the trial, saying those details will be determined by the advisory committee. Salix does not yet have a cost estimate for the new clinical study, but CFO Adam Derbyshire said that a previous phase 2b study and subsequent phase 3 trials cost $45 million. The retreatment study will be substantially less than that.
