FDA Okays New Linaclotide (Linzess) Dose for Constipation

Megan Brooks

January 27, 2017

Linaclotide (Linzess, Ironwood Pharmaceuticals/Allergan) is now available in 72-μg capsules for treatment of adults with chronic idiopathic constipation (CIC), the companies announced.

The new US Food and Drug Administration (FDA)–approved dose will provide physicians with "dosing flexibility based on individual presentation or tolerability, in treating the large and heterogenous population of adult CIC patients," the companies said in a joint news release.

The new dose is expected to be available in the first quarter of 2017.

Linaclotide is now available in three dosage strengths: 290 μg for adults with irritable bowel syndrome with constipation (IBS-C) and 145 μg and 72 μg for adults with CIC.

Taken once daily at least 30 minutes before the first meal of the day, linaclotide helps relieve the abdominal pain and constipation associated with IBS-C, as well as the constipation, infrequent stools, hard stools, and incomplete evacuation associated with CIC.

The approval of linaclotide 72 μg is based on results from a phase 3 clinical trial involving more than 1200 adults with CIC. Compared with placebo, the 72-μg dose demonstrated statistically significant improvement in complete spontaneous bowel movements over 12 weeks.

The most common adverse event was diarrhea, although the rates of diarrhea and of discontinuation due to diarrhea were numerically lower for the 72-μg dose than for the 145-μg dose in this trial, the companies said.

Linaclotide has met all primary endpoints in each of the five pivotal US phase 3 trials, spanning three doses and two indications, the companies note.

Linaclotide is contraindicated in pediatric patients younger than age 6 years. The safety and effectiveness of linaclotide in children younger than 18 have not been established. Linaclotide is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

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