Ironwood and Allergan announced that the Food and Drug Administration (FDA) has approved a new 72mcg dose of Linzess (linaclotide) for the treatment of chronic idiopathic constipation (CIC) in adults.
In June 2016, the FDA accepted for review the supplemental New Drug Application (sNDA) for the 72mcg dose. Linzess, a guanylate cyclase-C (GC-C) agonist, is currently available in a 290mcg strength to treat adults with irritable bowel syndrome with constipation (IBS-C). The 145mcg and the new 72mcg doses are approved to treat adults with CIC.
The approval of Linzess 72mcg was based on data from a Phase 3 trial (n=1,223) of adults with CIC. The 72mcg dose showed statistically significant improvement in Complete Spontaneous Bowel Movement (CSBM) vs. placebo over 12 weeks. The rates of diarrhea and discontinuation due to diarrhea were less in the 72mcg dose group vs. the 145mcg dose group in the study.
The new 72mcg dose is anticipated to launch in the first quarter of 2017. The 145mcg and 290mcg strength capsules are already available in 30-count bottles.
For more information call (800) 433-8871 or visit Linzess.com.