Pharmacist Medication Insights: Linaclotide (Linzess) for IBS, CIC

Linaclotide (Linzess) is a guanylate cyclase-C agonist indicated in adults for treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).

Linzess comes in a once-daily capsule, and helps relieve symptoms of IBS-C and CIC, such as abdominal pain, constipation, infrequent stools, hard stools and incomplete evacuation associated with CDC.

Linzess was initially approved by the FDA in August 2012 and launched in December 2012.

The most recent approval for linaclotide was an additional dosing of 72 mcg for the treatment of CIC in adult patients. The drug is available in 3 dosage strengths: 290 mcg for adult patients with IBS-C, 145 mcg, and the 72 mcg.

The approval was based on results from a phase 3 clinical trial of 1223 adults with CIC. The 72-mcg dose successfully demonstrated improvement in complete spontaneous bowel movements compared to a placebo over a 12-week period. Linzess met all primary endpoints in its 5 US phase 3 trials, which spanned 3 doses and 2 indications.

The most common adverse effect of Linzess that patients experienced was diarrhea, although adverse events were lower for the 72-mcg dose than the 145-mcg dose.