The U.S. Food and Drug Administration has granted Trulance, which is manufactured by Synergy Pharmaceuticals Inc (NASDAQ:SGYP), approval. Trulance is used to treat chronic idiopathic constipation in adults. The chairman and chief executive officer of Synergy Pharmaceuticals, Gary S. Jacob, welcomed the development.
“We are thrilled with the approval of TRULANCE because it provides an additional, much-needed, new treatment option to help adults with chronic idiopathic constipation and their healthcare providers manage this condition,” said Jacob.
Approximately 42 million people suffer from constipation according to data from the National Institutes of Health. When a person is suffering from persistent constipation that lacks biochemical or structural explanation, the diagnosis is known as chronic idiopathic constipation. Trulance is consumed orally once a day and supports regular bowel function by stimulating the secretion of intestinal fluid.
Trials to test the efficacy and safety of Trulance were conducted among adult participants numbering 1,775. The trials took three months and were placebo-controlled. Those participating in the trial were randomly given either Trulance or a placebo once a day.
Candidates were required to have been diagnosed with constipation for a period of at least half a year in order to be allowed participation in the trial. The candidates were also required to have had fewer than three weekly defecations in the previous 90 days. They also needed to exhibit other symptoms that are associated with constipation.
Results of the trial showed that those who received Trulance were able to have more frequent bowel movements compared to those who received a placebo.
Trulance is, however, not recommended for children under the age of six years since it can lead to serious dehydration. And because the effectiveness and safety of Trulance has not been tested and verified in patients under the age of 18 years, the drug is also not recommended for this age group either. One of the side effects noted with the use of Trulance was diarrhea and patients who experience this should stop their prescription and consult their physician.
In Thursday’s trading, Synergy Pharmaceuticals Inc fell by 1.84% to close the day at $6.41.