Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Medicines licensing

New drug for chronic constipation approved by US Food and Drug Administration

The US Food and Drug Administration has approved plecanatide (Trulance; Synergy Pharmaceuticals) as another option for the treatment of chronic idiopathic constipation (CIC) in adults.

Plecanatide, which should be taken daily, supports regular bowel function by stimulating the upper gastrointestinal tract to secrete intestinal fluid.

In two 12-week trials, patients receiving the drug once daily were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those receiving placebo. They also reported improvements in stool frequency and consistency and straining. The two trials included 1,775 adults who had been diagnosed with constipation at least six months previously and had fewer than three defecations per week in the previous three months, as well as other symptoms associated with constipation. The most common and serious side effect was diarrhoea.

Plecanatide should not be used in patients with known or suspected mechanical gastrointestinal obstruction, and patients should stop taking the drug if they experience severe diarrhoea.

Children under 6 should not be given the drug owing to the risk of serious dehydration, and it should be avoided in patients aged 6 to 18 years because its safety and effectiveness have not been established in this age group.

Julie Beitz, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, says: “No one medication works for all patients suffering from chronic gastrointestinal disorders. With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition.”

 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202227

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Drugs of Abuse

    Drugs of Abuse

    A concise, easy-to-read guide for healthcare professionals who encounter drug abuse.

    £38.00Buy now
  • Pharmaceutical Toxicology

    Pharmaceutical Toxicology

    Explains the methodology and requirements of pre-clinical safety assessments of new medicines. Includes registration requirements and pharmacovigilance.

    £40.00Buy now
  • Adverse Drug Reactions

    Adverse Drug Reactions

    A practical guide to the drug reactions that affect particular organ systems, and the management of these reactions.

    £38.00Buy now
  • English Delftware Drug Jars

    English Delftware Drug Jars

    This beautiful book illustrates the art and history of the collection of English delftware drug jars in the Museum of the Royal Pharmaceutical Society of Great Britain.

    £54.00Buy now
  • Paediatric Drug Handling

    Paediatric Drug Handling

    Written for new pharmaceutical scientists, this book provides a background in paediatric pharmacy and a comprehensive introduction to children's medication.

    £33.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • US /FDA building

Jobs you might like

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.