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29 Jan 2017

USFDA approved new drug Trulance for Chronic Idiopathic Constipation

Brand Name: Trulance
Molecule: Plecanatide
Indicaton: for the treatment of Chronic Idiopathic Constipation (CIC) in adult patients
Company: Synergy Pharmaceuticals

Trulance, taken orally once daily, works locally in the upper GI tract to stimulate secretion of intestinal fluid and support regular bowel function.

The safety and efficacy of Trulance were established in two 12-week, placebo-controlled trials including 1,775 adult participants. Participants were randomly assigned to receive a placebo or Trulance, once daily. Participants in the trials were required to have been diagnosed with constipation at least six months prior to the study onset and to have less than three defecations per week in the previous three months, as well as other symptoms associated with constipation. Participants receiving Trulance were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those receiving placebo, and also had improvements in stool frequency and consistency and straining.

Trulance should not be used in children less than six years of age due to the risk of serious dehydration. Trulance should be avoided in patients six years of age to 18 years of age. The safety and effectiveness of Trulance have not been established in patients less than 18 years of age. Trulance should not be used in patients with known or suspected mechanical gastrointestinal obstruction.

Constipation is defined as reduced stool frequency or less than 3 times per week or difficulty passing stools, or both. The frequency of 3 times per week is different from different individuals. For some this may be a normal habit and any change or reduction in frequency is considered to be constipation in these individuals.

Chronic Idiopathic Constipation (CIC) is defined as the chronic presence of these symptoms. It is called idiopathic because the cause of this type of constipation is unknown and it is not caused by underlying illness or medication.

Symptoms of chronic idiopathic constipation include

  • Constipation or difficulty in passing stools
  • Hard and lumpy stools
  • Straining when defecating
  • Feeling of incomplete evacuation after completion
  • Abdominal pain
  • Abdominal discomfort and bloating
  • Excessive flatulence
  • Poorer physical functioning
  • Poor social functioning
  • Decreased quality of life and perception of health

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