Ironwood and Allergan announced that the Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the 72mcg dose of linaclotide for the treatment of adults with chronic idiopathic constipation (CIC).
The sNDA submission was supported by efficacy and safety data from a double-blind, placebo-controlled Phase 3 trial of 1,223 adult patients with CIC.
The FDA Prescription Drug User Fee Act (PDUFA) target action date for the sNDA is expected to occur in early 2017. If approved, the 72mcg dose would provide an additional treatment option for patients with CIC.
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist currently available as Linzess 145mcg capsule for the treatment of adults with CIC and 290mcg capsule for the treatment of irritable bowel syndrome with constipation (IBS-C).