Here’s what you should know:
1. The FDA previously approved Trulance for the treatment of adults with chronic idiopathic constipation. The FDA is evaluating how adults with IBS-C respond to Trulance.
2. In two phase III clinical trials, both 3 mg and 6 mg doses of Trulance were statistically significant compared to a placebo when used to treat IBS-C.
3. Synergy Pharmaceutical’s CEO Gary Jacobs, PhD, said in a release, “This acceptance by the FDA is an important step forward for Synergy, building on the recent FDA approval and launch of Trulance for adults with CIC, and signaling the next step in our efforts to bring Trulance to the many millions of people living with IBS-C.”
More articles on gastroenterology:
Gut microbiome-based IBS associated with brain structure alterations — 5 study insights
GI leader to know: Dr. John Haydek of Gastrointestinal Associates
Takeda plans to relocate 100 researchers to US — 3 insights
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