FDA approves Trulance for chronic idiopathic constipation

 

Trulance, a once-daily oral medication for chronic idiopathic constipation, has been approved by the Food and Drug Administration for adult patients as of Jan. 19.

Manufactured by Synergy Pharmaceuticals, Trulance (plecanatide) stimulates intestinal fluid secretion in the upper GI tract. Its efficacy and safety were determined to be sufficient in two 12-week placebo-controlled trials (NCT01982240 and NCT02122471). Participants taking Trulance were more likely than were those taking placebo to have improved bowel function and stool.

The safety of the medication has not been established for patients younger than 18 years of age. It should not be taken by adult patients with a known or suspected mechanical gastrointestinal obstruction. Its most common side effect is diarrhea.

The FDA’s statement noted that “an estimated 42 million people are affected by constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and for whom there is no structural or biochemical explanation.”

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Trulance, a once-daily oral medication for chronic idiopathic constipation, has been approved by the Food and Drug Administration for adult patients as of Jan. 19.

Manufactured by Synergy Pharmaceuticals, Trulance (plecanatide) stimulates intestinal fluid secretion in the upper GI tract. Its efficacy and safety were determined to be sufficient in two 12-week placebo-controlled trials (NCT01982240 and NCT02122471). Participants taking Trulance were more likely than were those taking placebo to have improved bowel function and stool.

The safety of the medication has not been established for patients younger than 18 years of age. It should not be taken by adult patients with a known or suspected mechanical gastrointestinal obstruction. Its most common side effect is diarrhea.

The FDA’s statement noted that “an estimated 42 million people are affected by constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and for whom there is no structural or biochemical explanation.”

[email protected]

 

Trulance, a once-daily oral medication for chronic idiopathic constipation, has been approved by the Food and Drug Administration for adult patients as of Jan. 19.

Manufactured by Synergy Pharmaceuticals, Trulance (plecanatide) stimulates intestinal fluid secretion in the upper GI tract. Its efficacy and safety were determined to be sufficient in two 12-week placebo-controlled trials (NCT01982240 and NCT02122471). Participants taking Trulance were more likely than were those taking placebo to have improved bowel function and stool.

The safety of the medication has not been established for patients younger than 18 years of age. It should not be taken by adult patients with a known or suspected mechanical gastrointestinal obstruction. Its most common side effect is diarrhea.

The FDA’s statement noted that “an estimated 42 million people are affected by constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and for whom there is no structural or biochemical explanation.”

[email protected]