Ironwood pharmaceutical Inc. And Allergan Plc announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the 72 mcg dose of linaclotide for use in the treatment of adults with chronic idiopathic constipation (CIC).
Chronic idiopathic constipation (CIC) is a functional gastrointestinal disorder estimated to impact as many as 35 million adult Americans. CIC is generally characterized by infrequent bowel movements (less than three times per week), but symptoms vary across this broad and heterogeneous patient population and may also include recurrent straining, lumpy or hard stools, and/or a sensation that the bowels are not fully empty.
The sNDA for the 72 mcg dose of linaclotide is based on efficacy and safety data from a double-blind, placebo-controlled Phase III clinical trial of 1,223 adult patients with CIC. The FDA Prescription Drug User Fee Act (PDUFA) target action date is expected to occur in early 2017.
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that is thought to work in two ways based on nonclinical studies. Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine.
Linaclotide is currently approved by the FDA for the treatment of adults with CIC as a 145 mcg capsule to be taken once per day. In addition, it is approved for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) as a 290 mcg capsule to be taken once per day. Since FDA approval in December of 2012, more than 1 million unique patients have filled a prescription for linaclotide, according to IMS Health.
