FDA Approves New Dose for Chronic Idiopathic Constipation Drug

The FDA has approved Ironwood and Allergan’s Linzess (linaclotide) for an additional dosing of 72 mcg. Linzess, which is indicated for the treatment of chronic idiopathic constipation (CIC) in adult patients, is now available in 3 dosage strengths: 290 mcg for adult patients with irritable bowel syndrome with constipation (IBS-C), 145 mcg, and the new 72 mcg.

The newly approved dose is 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.

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 newest dose will be available in the first quarter of 2017.

Reference

US Food and Drug Administration Approves 72 mcg Dose of LINZESS (linaclotide) for Adults with Chronic Idiopathic Constipation [news release]. Massachusetts and Dublin. Allergan’s website. http://www.allergan.com/NEWS/News/Thomson-Reuters/U-S-Food-and-Drug-Administration-Approves-72-mcg-D. Accessed Jan 26, 2017.