This article is more than 5 years old. Information may no longer be current.

FDA approves linaclotide for IBS, chronic constipation

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA today approved linaclotide to treat adults with certain varieties of irritable bowel syndrome.

Linaclotide (Linzess, Ironwood Pharmaceuticals, Forest Laboratories) was approved to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation, according to an FDA press release.

Linzess capsules are taken once daily at least 30 minutes before the first meal, helping bowel movements occur more frequently and relieving constipation. The drug also may ease abdominal pain in IBS-C, according to the press release.

Two double blind studies established the safety and effectiveness of Linzess, involving 1,604 patients randomly assigned to take 290 mcg of the medication for at least 12 weeks. The studies showed that — compared with placebo — it reduced abdominal pain and increased the number of complete spontaneous bowel movements. Diarrhea was the most common side effect reported.

The FDA approval includes a warning that Linzess should not be taken by patients aged 16 years and younger.