Patients suffering from irritable bowel syndrome with constipation (IBS-C) may benefit from a new drug making its way through the approval pipeline.
Synergy Pharmaceuticals reported positive top-line results on the first phase 3 trial investigating the efficacy and safety of the orally administered compound, plecanatide.
The plecanatide phase 3 trial IBS-C program included two randomized, 12-week, double-blind, placebo controlled trials assessing 3mg and 6mg doses in 1,135 patients.
Preliminary analyses suggested both doses met the study’s primary endpoint – high percentage of patients categorized as “overall responders” during the 12-week treatment compared to placebo.
What did this mean for patients?
According to the US Food and Drug Administration (FDA,) an overall responder is a patient who experiences at least 30% reduction in “worst abdominal pain” and an increase in at least one complete spontaneous bowel movement (CSBM) for six weeks of treatment. In this phase 3 trial, there were 21.5% overall responders in the 3mg group and 24% in the group administered 6mg.
Researchers used Rome 3 criteria to select the study participants who had a history of constipation and stomach pain for a minimum of 6 months. The criteria also required the patients to present symptoms of:
1. Hard or lumpy stools for 25% or more defecations
2. Loose or watery stools for 25% or less defecations
3. Discomfort or pain in the abdomen for three or more days each month for the last three months
According to the results, the most commonly reported adverse event was diarrhea, occurring in 3.2% of patients administered 3mg plecanatide and 3.7% incidences in the group given 6mg of the peptide.
According to Gary S. Jacob, PhD, Chairman and CEO of Synergy Pharmaceuticals Inc., quoted in a news release
, “These data reinforce our strong belief that plecanatide may represent an important new treatment option for the millions of patients currently suffering from IBS-C.” The team hopes to receive results from the second plecanatide phase 3 IBS-C trial before the year’s end.
Plecanatide is also under FDA review for treating chronic idiopathic constipation (CIC), with company plans to file the New Drug Application Supplement early next quarter.
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